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2019v1.0
Pharmacology
LILLEY'S
for Canadian Health Care Practice
i
TA B L E O F C O N T E N T S
About the Authors, v
Reviewers, vii
Preface, ix
Acknowledgements, xiii
PART 1 Pharmacology Basics
1
2
3
4
5
6
7
8
9
10
Nursing Practice in Canada and Drug Therapy, 1
Pharmacological Principles, 14
Legal and Ethical Considerations, 36
Patient-Focused Considerations, 47
Gene Therapy and Pharmacogenomics, 67
Medication Errors: Preventing and Responding, 75
Patient Education and Drug Therapy, 88
Over-the-Counter Drugs and Natural Health Products, 98
Vitamins and Minerals, 111
Principles of Drug Administration, 133
PART 2 Drugs Affecting the Central Nervous System
11
12
13
14
15
16
17
18
Analgesic Drugs, 164
General and Local Anaesthetics, 195
Central Nervous System Depressants and Muscle Relaxants, 214
Central Nervous System Stimulants and Related Drugs, 228
Antiepileptic Drugs, 244
Antiparkinsonian Drugs, 262
Psychotherapeutic Drugs, 278
Substance Misuse, 308
PART 3 Drugs Affecting the Autonomic Nervous System
19
20
21
22
Adrenergic Drugs, 325
Adrenergic-Blocking Drugs, 338
Cholinergic Drugs, 350
Cholinergic-Blocking Drugs, 361
PART 4 Drugs Affecting the Cardiovascular and Renal
Systems
23
24
25
26
27
28
29
30
Antihypertensive Drugs, 371
Antianginal Drugs, 394
Heart Failure Drugs, 408
Antidysrhythmic Drugs, 423
Coagulation Modifier Drugs, 444
Antilipemic Drugs, 469
Diuretic Drugs, 485
Fluids and Electrolytes, 500
PART 5 Drugs Affecting the Endocrine System
31
32
33
34
Pituitary Drugs, 519
Thyroid and Antithyroid Drugs, 528
Antidiabetic Drugs, 537
Adrenal Drugs, 563
35 Women’s Health Drugs, 574
36 Men’s Health Drugs, 596
PART 6 Drugs Affecting the Respiratory System
37 Antihistamines, Decongestants, Antitussives, and Expectorants, 606
38 Respiratory Drugs, 621
PART 7 Drugs Affecting the Gastrointestinal System
and Nutrition
39
40
41
42
Acid-Controlling Drugs, 640
Antidiarrheal Drugs and Laxatives, 654
Antiemetic and Antinausea Drugs, 667
Nutritional Supplements, 679
PART 8 Anti-infective and Anti-inflammatory Drugs
43 Antibiotics Part 1: Sulfonamides, Penicillins, Cephalosporins,
Macrolides, and Tetracyclines, 691
44 Antibiotics Part 2: Aminoglycosides, Fluoroquinolones, and
Other Drugs, 715
45 Antiviral Drugs, 731
46 Antitubercular Drugs, 753
47 Antifungal Drugs, 764
48 Antimalarial, Antiprotozoal, and Anthelmintic Drugs, 774
49 Anti-inflammatory and Antigout Drugs, 789
PART 9 Immune and Biological Modifiers and
Chemotherapeutic Drugs
50 Immunosuppressant Drugs, 804
51 Immunizing Drugs and Pandemic Preparedness, 815
52 Antineoplastic Drugs Part 1: Cancer Overview and Cell
Cycle–Specific Drugs, 832
53 Antineoplastic Drugs Part 2: Cell Cycle–Nonspecific and
Miscellaneous Drugs, 859
54 Biological Response–Modifying Drugs and Antirheumatic
Drugs, 872
PART 10 Miscellaneous Therapeutics: Hematological,
Dermatological, Ophthalmic, and Otic Drugs
55
56
57
58
Anemia Drugs, 892
Dermatological Drugs, 903
Ophthalmic Drugs, 918
Otic Drugs, 939
Appendix: Pharmaceutical Abbreviations, 945
Answers to Review Questions, 946
Bibliography, 949
Index of Glossary Terms, 966
Drug Index, 973
General Index, 981
FOURTH EDITION
Pharmacology
LILLEY'S
for Canadian Health Care Practice
Kara SEALOCK, RN, BN, MEd, EdD
Senior Instructor, Faculty of Nursing
University of Calgary
Calgary, Alberta
Cydnee SENEVIRATNE, RN, BScN, MN, PhD
Senior Instructor, Faculty of Nursing
University of Calgary
Calgary, Alberta
US Authors
Linda LANE LILLEY, RN, PhD
University Professor and Associate Professor Emeritus (Retired)
School of Nursing
Old Dominion University
Norfolk, Virginia
Shelly RAINFORTH COLLINS, PharmD
President, Drug Information Consultants
Chesapeake, Virginia
Julie S. SNYDER, MSN, RN-BC
Lecturer School of Nursing
Regent University
Virginia Beach, Virginia
LILLEY’S PHARMACOLOGY FOR CANADIAN HEALTH CARE PRACTICE,
FOURTH EDITION
Copyright © 2021, Elsevier Inc. All rights reserved.
ISBN: 978-0-323-69480-3
Adapted from Pharmacology and the Nursing Process, Ninth Edition, by Linda Lane Lilley, Shelly Rainforth
Collins and Julie S. Snyder. Copyright © 2019 by Elsevier Inc.
978-0-323-52949-5 (softcover)
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval
system, without permission in writing from the publisher. Reproducing passages from this book without such
written permission is an infringement of copyright law.
Requests for permission to make copies of any part of the work should be mailed to: College Licensing Officer, access ©, 1 Yonge Street, Suite 1900, Toronto, ON, M5E 1E5. Fax: (416) 868–1621. All other inquiries should
be directed to the publisher, www.elsevier.com/permissions.
Every reasonable effort has been made to acquire permission for copyright material used in this text and to
acknowledge all such indebtedness accurately. Any errors and omissions called to the publisher’s attention will
be corrected in future printings.
This book and the individual contributions contained in it are protected under copyright by the Publisher
(other than as may be noted herein).
Notice
Practitioners and researchers must always rely on their own experience and knowledge in evaluating
and using any information, methods, compounds or experiments described herein. Because of rapid
advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages
should be made. To the fullest extent of the law, no responsibility is assumed by Elsevier, authors, editors
or contributors for any injury and/or damage to persons or property as a matter of products liability,
negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas
contained in the material herein.
International Standard Book Number: 978-0-323-69480-3
VP Education Content: Kevonne Holloway
Content Strategist (Acquisitions, Canada): Roberta A. Spinosa-Millman
Director, Content Development Manager: Laurie Gower
Content Development Specialist: Theresa Fitzgerald
Publishing Services Manager: Julie Eddy
Senior Project Manager: Richard Barber
Design Direction: Amy Buxton
Printed in Canada
Last digit is the print number: 9
8
7 6
5
4
3
2 1
A B O U T T H E AU T H O R S
KARA SEALOCK
LINDA LANE LILLEY
Dr. Kara Sealock completed a Bachelor of Nursing in 2000, a
Masters of Education in 2012, and a Doctorate of Education,
specializing in adult learning, in 2019. Kara has been a nursing educator since 2008 and has worked in various roles such
as a preceptor, clinical instructor, and theory instructor with
a focus in medical/surgical care, critical care, and gerontology. Kara teaches pathophysiology, assessment, and pharmacology at the University of Calgary. She has considerable
years of clinical experience in medical/surgical environments,
research experience working with cardiology and endocrinology clients; however, the majority of her career has been
positioned in critical care with an adult focus in intensive
care and coronary care environments. Kara has substantive
experience in preparing undergraduate nursing students for
NCLEX-RN as she has facilitated preparation workshops and
mock examination opportunities, and assumes an active role
in preparing students for success. She currently sits on the
Nursing Education Program Approval Committee at the College and Association of Registered Nurses (CARNA). Kara’s
knowledge in adult learning, combined with her clinical and
theoretical experience contributes to an enhanced foundation
of learning bridging theory and practice for undergraduate
nursing education. Kara is currently a senior instructor with
a specific focus in teaching for the Faculty of Nursing at the
University of Calgary.
Dr. Linda Lilley received her diploma from Norfolk General
School of Nursing, BSN from the University of Virginia, Master
of Science (Nursing) from Old Dominion University, and PhD
in Nursing from George Mason University. As an Associate Professor Emeritus and University Professor at Old Dominion University, her teaching experience in nursing education spans over
25 years, including almost 20 years at Old Dominion. Linda’s
teaching expertise includes drug therapy and the nursing process, adult nursing, physical assessment, fundamentals in nursing, oncology nursing, nursing theory, and trends in health care.
The awarding of the university’s most prestigious title of University Professor reflects her teaching excellence as a tenured faculty
member. She has also been a two-time university nominee for the
State Council of Higher Education in Virginia award for excellence in teaching, service, and scholarship. Linda received the
2012 Distinguished Nursing Alumni Award from Old Dominion University School of Nursing for her “continued work on the
successful pharmacology textbook published by Elsevier” and to
recognize her “extraordinary work and the impact [the book]
has had on baccalaureate education.” While at Old Dominion
University, Linda mentored and taught undergraduate and graduate students as well as registered nurses returning for their BSN.
Linda authored the MED ERRORS column for the American
Journal of Nursing between 1994 and 1999, as well as numerous
other peer-reviewed, published articles in professional nursing
journals. Since retiring in 2005, Linda continues to be active in
nursing, serving as a member on dissertation committees with
the College of Health Sciences and maintaining membership
and involvement in numerous professional and academic organizations. Since January of 2014, Dr. Lilley continues to serve on
the volunteer review panel for the monthly newsletter publication Nurse Advise-ERR (ISMP affiliated; the ISMP [Institute for
Safe Medication Practices] is a nonprofit organization educating
the healthcare community and consumers about safe medication
practices). Linda has served as a consultant with school nurses
in the city of Virginia Beach and as a member on the City of
Virginia Beach’s Health Advisory Board. Linda also served as an
appointed member on the national advisory panel on medication error prevention with the U.S. Pharmacopeia in Rockville,
Maryland. She continues to educate nursing students and professional nurses about drug therapy and the nursing process and
speaks on the topics of drug therapy, safe medication use, humor
and healing, and grief and loss.
CYDNEE SENEVIRATNE
Dr. Cydnee Seneviratne received a diploma in Nursing in 1991
and has dedicated her career to advancing neuroscience nursing, chronic stroke care, and gerontology. She received a BScN
from the University of Victoria in 1995 and a Master of Nursing in 1997 from the University of Calgary. Cydnee received a
FUTURE Program for Cardiovascular Nurse Scientists Fellowship (a CIHR Strategic Training Program in Health Research)
while completing her PhD in 2007 at the University of Calgary
and completed a post-doctoral fellowship in 2010 funded by
the Heart and Stroke Foundation of Canada. Cydnee has been
a nursing instructor in clinical, laboratory, and classroom settings (specifically pharmacology and pathophysiology) at the
University of Calgary for 19 years and has remained closely
linked to the clinical setting during her time as the Associate
Dean of Undergraduate Practice Education. In the Associate
Dean role, she was chair of the Nursing Education Program
Approval Committee at the College and Association of Registered Nurses (CARNA) where she was instrumental in crafting
undergraduate and nurse practitioner program approval processes. Cydnee is currently a senior instructor and is a leader
in Interprofessional Simulation Education for the Faculty of
Nursing.
SHELLY RAINFORTH COLLINS
Shelly Rainforth Collins received her Doctor of Pharmacy
degree from the University of Nebraska, College of Pharmacy
in 1985, with High Distinction. She then completed a clinical
pharmacy residency at Memorial Medical Center of Long
Beach in Long Beach, California. She worked as a pediatric
v
vi
ABOUT THE AUTHORS
clinical pharmacist (neonatal specialist) at Memorial Medical Center before moving to Mobile, Alabama, where she
was the Assistant Director of Clinical Pharmacy Services at
Mobile Infirmary Medical Center. After moving to Chesapeake, Virginia, she served as the Clinical Pharmacy Specialist/Coordinator of Clinical Pharmacy Services at Chesapeake
Regional Medical Center in Chesapeake, Virginia for 19 years.
Her practice focused on developing and implementing clinical pharmacy services as well as medication safety and Joint
Commission medication management standards and national
patient safety goals. She is president of Drug Information Consultants, a business offering consultation and expert witness
review for attorneys on medical malpractice cases. She holds
certifications in Medication Therapy Management, Anticoagulation Management, and Immunizations. Shelly was awarded
the Clinical Pharmacist of the Year Award in 2007 from the
Virginia Society of Healthsystem Pharmacists. She led a multidisciplinary team that won the Clinical Achievement of the
Year Award from George Mason University School of Public
Health in 2007 for promoting safety with narcotics in patients
with sleep apnea; this program has also received national recognition. She was awarded the Service Excellence Award from
Chesapeake Regional Medical Center. Shelly’s professional
affiliations include the American Society of Healthsystem
Pharmacists, the Virginia Society of Healthsystem Pharmacists, and the American Pharmacists Association.
JULIE S. SNYDER
Julie Snyder received her diploma from Norfolk General Hospital School of Nursing and her BSN and MSN from Old Dominion University. After working in medical-surgical nursing, she
worked in nursing staff development and community education.
Later, she transferred to the academic setting and taught fundamentals of nursing, pharmacology, physical assessment, and adult
medical-surgical nursing at a university school of nursing. Julie
has recently worked as a Quality Initiative Coordinator and a
Clinical Nurse Educator in a local hospital. She is now a Lecturer
at the School of Nursing of Regent University in Virginia Beach,
Virginia. She has been certified by the ANCC in Nursing Continuing Education and Staff Development and currently holds
ANCC certification in Medical-Surgical Nursing. She is a member of Sigma Theta Tau International and was inducted into Phi
Kappa Phi as Outstanding Alumni for Old Dominion University.
She has worked for Elsevier as a reviewer, ancillary writer, and
author since 1997. Julie’s professional service has included serving
on the Virginia Nurses’ Association Continuing Education Committee, serving as Educational Development Committee chair for
the Epsilon Chi chapter of Sigma Theta Tau, serving as an item
writer for the ANCC, working with a regional hospital educators’
group, and serving as a consultant on various projects for local
hospital education departments. In addition, she has conducted
pharmacology review classes for recent nursing graduates.
REVIEWERS
Paula Crawford-Dickinson, RN, BScN, BA, BHA,
MN-ACNP, EdD
Professor
Sally Horsfall-Eaton School of Nursing
George Brown College
Toronto, Ontario
Kerry Lynn Durnford, RN, MN
Instructor School of Health and Human Services
Aurora College
Yellowknife, Northwest Territories
Joanna Gallacher, RN, MN
Professor
Practical Nursing Program
School of Health & Community Services
Durham College
Oshawa, Ontario
Stacy E. Hunt, RN, BSN, MSN
Nursing Faculty
Saskatchewan Collaborative Bachelor of Science in Nursing
Program
School of Nursing
Saskatchewan Polytechnic
Regina, Saskatchewan
Lindsay MacFarlane, HBScN, MEd, OCT, RN
Professor, Practical Nursing
School of Health and Community Services
Confederation College
Thunder Bay, Ontario
Wanda Pierson, RN, BSN, MSN, MA, PhD
Faculty, Faculty of Nursing
Langara College
Vancouver, British Columbia
Kelly Marie Power-Kean, RN, BN, MHS, NP
Nurse Educator, Nurse Practitioner
Nursing Education
Centre for Nursing Studies, and Memorial University of
Newfoundland
St. John’s, Newfoundland
Heather Scarlett-Ferguson, BSP, MEd, EdD, RPh
Instructor
Psychiatric Nursing
MacEwan University
Edmonton, Alberta
Joy Shewchuk, RN, BSc, BSN, MSN
Professor, Nursing
School of Health Sciences
Humber College Institute of Technology and Advanced
Learning
Toronto, Ontario
Ruth Swart, EdD, MHS, RN, BN, BSc
Senior Instructor
Faculty of Nursing
University of Calgary
Calgary, Alberta
Nadia Torresan-Doodnaught, BScN, RNC, MN
Professor of Nursing
Faculty of Health Sciences
Seneca College of Applied Arts and Technology
King City, Ontario
Kari Dawn Ubels, CD, HBScN, RN
Associate Chair of Practical Nurse Curriculum
Faculty of Health and Community Studies
NorQuest College
Edmonton, Alberta
Jess White, RN, BN, ENC(C)
Faculty, Practical Nursing
Assiniboine College
Winnipeg, Manitoba
Stephanie Zettel, RN, MN, BN, BSc (Honours)
Associate Professor School of Health Sciences
Department of Nursing
School of Nursing and Midwifery
Faculty of Health, Community and Education
Mount Royal University
Calgary, Alberta
vii
viii
REVIEWERS
PHARMD REVIEWERS
With special thanks to:
Grace Frankel, BSc Pharm, Pharm D, BCPS
Clinical Pharmacist
Primary Care/Hospital Practice, My Health Team, Southern
Health Region
Steinbach, Manitoba
Thomas McFarlane, BSc Pharm, Pharm D
Clinical Lecturer, Oncology
School of Pharmacy, University of Waterloo
Waterloo, Ontario
Karen Sutton, RN, BScN, MN, CNCC(C)
Professor, Practical Nursing Program
Coordinator, Critical Care Nursing Program
Durham College
Oshawa, Ontario
P R E FA C E
INTRODUCTION
The fourth edition of Lilley’s Pharmacology for Canadian Health
Care Practice incorporates both the nursing process and evidence in practice as it is relevant to Canadian nursing. This text
provides the most current and clinically relevant information in
an appealing, understandable, and practical format. The clear
writing style and full-colour design of Lilley’s Pharmacology for
Canadian Health Care Practice are ideal for today’s busy nursing
student. The book presents drug information that both RN and
PN nursing students need to know for whatever exam they are
preparing to take. It also provides information on what the professional nurse may encounter during drug administration in
a variety of health care settings, including accounts of real-life
medication errors and tips for avoiding those errors. Features
that help set the book apart include:
• A focus on the role of prioritization in nursing care
• A strong focus on drug classes to help students acquire a better knowledge of how various drug classes work in the body,
allowing them to apply this knowledge to individual drugs
• Canadian content relevant to Canadian students and educators that will strengthen their knowledge of the field
• Clinical practice guidelines produced or endorsed in Canada
by national, provincial, or territorial medical or health organizations, or by professional societies, government agencies,
or expert panels
• Ethnocultural examples that reflect the varied and complex
ethnodemographic diversity of Canada
• Ease of readability to make this difficult content more understandable
For this edition, the author team has not only focused on
providing the most “need-to-know” information but also the
most up to date research related to pharmaceuticals while
emphasizing the nursing process and prioritization. In addition,
a brief discussion of pharmacology related to transgender men
and women who may or may not be transitioning is included in
this edition. In future editions a more fulsome discussion will
be included in chapters 35 and 36. Many of the updates for this
edition are in response to student and instructor feedback.
MARKET RESEARCH
To aid in the preparation of this text, nursing instructors from
across Canada participated in extensive, detailed reviews of the
Third Canadian Edition. These reviewers assessed changes that
had occurred in the field of pharmacology since publication of
the third edition and determined what was needed to better
teach this subject to nursing students and how their evolving
learning needs could be met.
This Canadian edition maintains the philosophy of making
the challenging subject of pharmacology approachable and easy
to understand. Additional concerns raised and enhancements
suggested by educators and nursing students who served as
reviewers or consultants throughout the manuscript’s development, as well by the authors of this text, also have been
addressed.
ORGANIZATION
This book includes 58 chapters presented in 10 parts, organized
by body system. The 10 “concepts” chapters in Part 1 lay a solid
foundation for the subsequent drug units and address the following topics:
• The nursing process and drug therapy
• Pharmacological principles
• Legal and ethical considerations
• Ethnocultural and lifespan considerations related to pharmacology
• Gene therapy and pharmacogenomics
• Preventing and responding to medication errors
• Patient education and drug therapy
• Over-the-counter drugs and natural health products
• Vitamins and minerals
• Drug administration techniques, including 100 drawings
and photographs
Parts 2 through 10 present pharmacology and nursing
management in a time-tested body systems and drug function
framework. This approach facilitates learning by grouping functionally related drugs and drug groups. It provides an effective
means of integrating the content into medical-surgical/adult
health nursing courses or for teaching pharmacology in a separate course.
The 48 drug chapters in these 9 Parts constitute the main
portion of the book. Drugs are presented in a consistent format
with an emphasis on drug classes and key similarities and differences among the drugs in each class. Each chapter is subdivided
into two discussions, beginning with (1) a brief overview of relevant anatomy, physiology, and pathophysiology and a complete
discussion of pharmacology, followed by (2) a comprehensive
yet succinct application of the nursing process.
Pharmacology is presented for each drug group in a consistent format:
• Mechanism of Action and Drug Effects
• Indications
• Contraindications
• Adverse Effects (often including Toxicity and Management
of Overdose)
• Interactions
• Dosages
Drug class discussions conclude with specially highlighted
Drug Profiles—brief narrative “capsules” of individual drugs in
the class or group, including pharmacokinetics tables for each
drug. Key drugs (prototypical drugs within a class) are identified
throughout with a
symbol for easy identification.
The pharmacology section is followed by a Nursing Process
discussion that relates to the entire drug group. This nursing
ix
x
PREFACE
content is covered in the following, familiar nursing process
format:
• Assessment
• Nursing Diagnoses
• Planning (including Goals and Expected Patient Outcomes)
• Implementation
• Evaluation
At the end of each Nursing Process section is a Patient Teaching Tips box that summarizes key points for nursing students
and practising nurses to include in the education of patients
about their medications. These boxes focus on teaching how
the drugs work, possible interactions, adverse effects, and other
information related to the safe and effective use of the drug(s).
The role of the nurse as patient educator and advocate continues to grow in importance in professional practice, so there is
emphasis on this key content in each chapter in this edition.
Lilley’s Pharmacology for Canadian Health Care Practice also
reflects the latest drug information and research through the
following special boxes:
• Evidence in Practice
• Ethnocultural Implications
• Lab Values Related to Drug Therapy
• Legal and Ethical Principles
• Natural Health Products
• Preventing Medication Errors
• Special Populations: Adolescents
• Special Populations: Children
• Special Populations: The Older Adult
• Legal and Ethical Principles
• Pharmacokinetic Bridge to Nursing Process
NEW TO THIS EDITION
The hallmark readability and user-friendliness of Lilley’s Pharmacology for Canadian Health Care Practice helps students navigate easily through the textbook and thus the difficult subject of
pharmacology and the nursing process.
This textbook continues to feature “need-to-know” content
as well as up to date research related to pharmaceutical interventions and Canadian legislation. Information on drug adverse
effects reflects only the most common and most serious adverse
effects rather than listing all reported adverse effects. These
adverse effects are listed in order of those most commonly seen.
Another area continued from the previous addition is that of
drug dosages; only those dosages that are seen in most common
indications are included in the text and tables. (For other dosages, the student should refer to an up-to-date drug handbook
or drug reference such as, Mosby’s Canadian Nursing Drug Reference.) This need-to-know approach to drug indications and
adverse effects is crucial in helping the adult learner focus on
the most essential content needed for safe drug administration.
Drugs included in the text are as up-to-date as possible and
include related research to ensure students receive accurate
information. The availability of drugs changes frequently because
manufacturers discontinue production or as a result of shortages.
The use of abbreviations has been limited to the most
common abbreviations. While the use of abbreviations is not
encouraged overall, abbreviations are still approved and used by
agencies, and may also be part of the documentation method.
The Institute of Safe Medication Practices (ISMP) Canada’s “Do
Not Use List” of abbreviations, symbols, and dose designations
has been adhered to within this text.
It is important to remember that although this textbook
provides all of the need-to-know pharmacology content that
students will need for an entry level of practice, it is first and
foremost a nursing textbook rather than a pharmacology textbook, with a strong emphasis on the nursing process and professional nursing practice. The section on implementation also
offers all of the most essential information, followed by a section on the evaluation of therapeutic and adverse effects. These
changes highlight the significance of the nursing process as a
foundation in drug therapy while helping the student to make
strong cognitive connections among nursing diagnoses, goals,
and expected patient outcomes.
The pharmacology and nursing content in each of the 58
chapters has been thoroughly revised and critically reviewed by
nursing instructors, practising nurses, and PharmDs to reflect the
latest drug information and nursing content. Key updates include:
• Updated population and incidence statistics in each chapter
• Summary of Canadian cannabis/marihuana regulations and
the Cannabis Act in Chapter 3
• Revision of Chapters 4 and 7 include Indigenous health and
healing practices, an explanation of the Indigenous medicine
wheel, and alternative medicinal interventions in response to
the Truth and Reconciliation Commission of Canada’s Calls
to Action
• Revision of Chapter 11 includes an explanation of current
practices when/if an opioid overdose occurs in the community, including a stepwise explanation of how to administer
Naloxone
• Additional Examination Review Questions at the end of each
chapter
ADDITIONAL TEACHING AND LEARNING
FEATURES
The book also includes a variety of innovative teaching and learning features that prepare the student for important content to be
covered in each chapter and encourage review and reinforcement
of that content. Chapter-opener features include the following:
• Learning objectives
• Summary of Drug Profiles in the chapter, with page number
references
• List of High-Alert Drugs in the chapter, with page number
references
• Key terms with definitions and page number references (key
terms being in bold type throughout the narrative to emphasize this essential terminology)
The following features appear at the end of each chapter:
• Patient Teaching Tips related to drug therapy
• Key Points boxes summarizing important chapter content
• Examination Review Questions, with answers provided at
the end of the book for quick and easy review
• Critical Thinking activities
• List of Evolve Resources available to students
• References for works cited in the chapter
PREFACE
In addition to the special boxes listed previously, other special features that appear throughout the text include:
• Case Studies in every chapter, with answer guidelines provided on the Evolve website
• Dosages tables listing generic and trade names, pharmacological class, usual dosage ranges, and indications for the drugs
For a more comprehensive listing of the special features,
please see the inside back cover of the book.
COLOUR
The use of colour continues to complement the text by making the book engaging for nursing students. Colour is used
throughout to:
• Highlight important content
• Illustrate how drugs work in the body in numerous anatomical
and drug process colour illustrations
• Improve the visual appearance of the content to make it more
engaging and appealing to today’s more visually sophisticated reader
The use of colour and other visual engagement devices in
these ways significantly improves students’ involvement and
understanding of pharmacology.
SUPPLEMENTAL RESOURCES
A comprehensive ancillary package is available to students and
instructors using Lilley’s Pharmacology for Canadian Health
Care Practice. The following supplemental resources have been
thoroughly revised for this edition and can significantly assist in
the teaching and learning of pharmacology.
Study Guide
The student study guide—carefully aligned with the content and
focus of the book—includes the following:
• Student Study Tips that reinforce the Study Skills available
on the Evolve site and provide a “how to” guide to applying
test-taking strategies
• Worksheets for each chapter, with Examination Review
questions (with application-based, alternate-item, and dosage calculation questions), critical thinking and application
questions, and other activities
• Case Studies followed by related critical thinking questions
• An updated Overview of Dosage Calculations with helpful
tips for calculating doses, sample drug labels, practice problems, and a quiz
• Answers to all questions (provided in the back of the book)
to facilitate self-study
Evolve Web Site
Located at http://evolve.elsevier.com/Canada/Lilley/pharmacology, the Evolve Web site for this book includes the following
elements:
For Students
• More than 550 Review Questions for Exam Preparation
• Answers to Critical Thinking Activities from the book
• Printable Chapter Summaries for each chapter
xi
•
•
•
•
Answers to Case Studies from the book
Audio Glossary
Unfolding Case Studies
Integrated Study Skills Tips present valuable study skills topics related to each Part within the text, including time management, note-taking, studying, test-taking and others. These
tips help students learn the particularly demanding subject
of pharmacology while also equipping them with tools that
they can use in other courses and as lifelong learners who are
building an evidence-based practice.
• Book-specific Next Generation NCLEX Case Studies (both
single-episode and unfolding)
For Instructors
• TEACH for Nurses Lesson Plans that focus on the most important content from each chapter and provide innovative strategies for student engagement and learning. These new Lesson
Plans include strategies for integrating nursing curriculum
standards, links to all relevant student and instructor resources,
and an original instructor-only Case Study in each chapter.
• ExamView® Test Bank that features more than 800 examination−format test questions (including alternate-item questions)
with text page references, rationales, and answers coded for
NCLEX® Client Needs category, nursing process step, and cognitive level (Bloom’s taxonomy). The robust ExamView® testing
application, provided at no cost to faculty, allows instructors to
create new tests; edit, add, and delete test questions; sort questions by NCLEX® Client Needs category, cognitive level, and
nursing process step; and administer and grade tests online,
with automated scoring and gradebook functionality.
• PowerPoint® Lecture Slides consisting of more than 2100
customizable text slides for instructors to use in lectures. The
presentations include Unfolding Case Studies and applicable illustrations from the book’s Image Collection. Audience
Response System Questions (three or more discussion-oriented questions per chapter for use with i>Clicker and other
systems) are folded into these presentations.
• Generic Next Generation NCLEX Case Studies for Pharmacology (both single-episode and unfolding)
• An Image Collection with over 250 full-colour images from
the book for instructors to use in lectures
• Access to all student resources listed above
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xii
PREFACE
ICONS AT A GLANCE
ETHNOCULTURAL IMPLICATIONS
SPECIAL POPULATIONS: CHILDREN
NATURAL HEALTH PRODUCTS
SPECIAL POPULATIONS: OLDER ADULTS
DRUG PROFILES
HIGH-ALERT Drugs
LAB VALUES RELATED TO DRUG THERAPY
PREVENTING MEDICATION ERRORS
SPECIAL POPULATIONS: ADOLESCENTS
Key drug
NEXT GENERATION NCLEX
The National Council for the State Boards of Nursing (NCSBN)
is a not-for-profit organization whose members include nursing regulatory bodies. In empowering and supporting nursing
regulators in their mandate to protect the public, the NCSBN is
involved in the development of nursing licensure examinations,
such as the NCLEX-RN®. In Canada, the NCLEX-RN® was
introduced in 2015 and is, as of the writing of this text, the recognized licensure exam required for practising RNs in Canada.
The NCLEX-RN® will, as of 2023, be changing in order to
ensure that its item types adequately measure clinical judgement, critical thinking, and problem-solving skills on a consistent basis. The NCSBN will also be incorporating into the
examination what they call the Clinical Judgement Measurement Model (CJMM), which is a framework that the NCSBN
has created to measure a novice nurse’s ability to apply clinical
judgement in practice.
These changes to the examination come as a result of research
findings which indicated that novice nurses have a much higher-than-desirable error rate with patients (i.e., errors that cause
patient harm) and, upon NCSBN’s investigation, the discovery
that the overwhelming majority of these errors were caused by
failures of clinical judgement.
Clinical judgement has been a foundation underlying nursing education for decades, based on the work of a number of
nursing theorists. The theory of clinical judgement that most
closely aligns to what NCSBN is basing their CJMM is the work
by Christine A. Tanner.
The new version of the NCLEX-RN® is loosely being identified as the “Next-Generation NCLEX” or “NGN”, and will feature the following:
• 6 key skills in the CJMM: recognizing cues, analyzing cues,
prioritizing hypotheses, generating solutions, taking actions,
and evaluating outcomes.
• Approved item types as of June 2020: multiple response,
extended drag and drop, cloze (drop-down), enhanced hotspot (highlighting), and matrix/grid. More question types
may be added.
• All new item types are accompanied by mini-case studies
with comprehensive patient information—some of it relevant to the question, and some of it not.
• Case information may present a single, unchanging moment
in time (a “single episode” case study) or multiple moments
in time as a patient’s condition changes (an “unfolding” case
study).
• Single-episode case studies may be accompanied by 1-6 questions; unfolding case studies are accompanied by 6 questions.
For more information (and detail) regarding the NCLEX-RN®
and changes coming to the exam, visit the NCSBNs website:
https://www.ncsbn.org/11447.htm and https://ncsbn.org/Building _a_Method_for_Writing_Clinical_Judgment_It.pdf.
For further NCLEX-RN® examination preparation resources,
see Silvestri’s Canadian Comprehensive Review for the NCLEXRN Examination, Second Edition, ISBN 9780323709385.
Prior to preparing for any nursing licensure examination,
please refer to your provincial or territorial nursing regulatory
body to determine which licensure examination is required in
order for you to practice in your chosen jurisdiction.
WE WELCOME YOUR FEEDBACK
We always welcome comments from instructors and students
who use this book so that we may continue to make improvements and be responsive to your needs in future editions. Please
send any comments you may have for us to NHPInstructorPre
mier@reedelsevier.com.
ACKNOWLED GEMENTS
Our part in this book would not have been possible without the original efforts of the American
authors who conceptualized and wrote Pharmacology and the Nursing Process, which has shaped
the content of Lilley’s Pharmacology for Canadian Health Care Practice. Linda Lane Lilley, RN,
PhD; Shelly Rainforth Collins, PharmD; and Julie S. Snyder, MSN, RN, BC, are to be commended
for their thorough and expert handling of a vast and complex subject matter and for creating
an excellent foundation over which the Canadian content could be easily laid. We would like to
express our gratitude to Beth Swart, the author of the inaugural Canadian editions of Pharmacology for Canadian Health Care Practice, 1ce–3ce. Over the years, she has written and revised an
exemplar textbook used in nursing curricula across Canada. We thank her for her dedication and
commitment to nursing education.
We dedicate Lilley’s Pharmacology for Canadian Health Care Practice to our students, both past
and present, who inspire us with their curiosity for learning, passion for the nursing profession,
and dedication to caring for the Canadian population. We could not have met the challenges of
authoring this pharmacology textbook without the support and understanding from our families
and colleagues.
We could not have accomplished this project without the assistance of Theresa Fitzgerald, who
encouraged, altered deadlines to fit our busy schedules, reminded us of deadlines, and supported
us throughout the huge task of co-editing this book. Roberta A. Spinosa-Millman, Content
Strategist at Elsevier Canada, who provided this opportunity for both of us. Many individuals at
Elsevier are responsible for this Canadian edition. Our thanks go to Laurie Gower, Content Director; Sherry Hinman, Copy Editor; Jerri Hurlbutt, Copy Editor; and Richard T. Barber, Senior
Project Manager for handling all the details involved in the final production of the book.
Thanks are due to the Canadian reviewers who reviewed content of this book and gave their
invaluable comments, expertise, and editing suggestions on the draft manuscript. As existing diseases and disorders and their treatments evolve, bringing with them new challenges and information in pharmacology, we will no doubt be looking forward to future editions of this textbook.
Dr. Kara Sealock, RN, EdD, MEd, BN, CNCC (C), CCNE
Dr. Cydnee Seneviratne, RN, PhD, MN, BSc
xiii
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CONTENTS
About the Authors, v
Reviewers, vii
Preface, ix
Acknowledgements, xiii
7
PART 1 Pharmacology Basics
1 Nursing Practice in Canada and Drug Therapy, 1
Overview, 1
Assessment, 2
Analysis of Data, 4
Nursing Diagnoses, 4
Planning, 6
Implementation, 6
Evaluation, 10
Evidence-Informed Practice, 11
2 Pharmacological Principles, 14
Overview, 16
Pharmaceutics, 17
Pharmacokinetics, 19
Pharmacodynamics, 28
Pharmacotherapeutics, 29
Pharmacognosy, 33
Pharmacoeconomics, 33
Toxicology, 33
Summary, 34
3 Legal and Ethical Considerations, 36
Legal Considerations, 37
New Drug Development, 39
Health Canada Drug Approval Process, 40
Legal Nursing Considerations and Drug
Therapy, 42
Ethical Considerations, 43
4 Patient-Focused Considerations, 47
Overview, 47
Assessment, 60
Nursing Diagnoses: Age-Related, 61
Planning, 61
Implementation, 62
Evaluation, 63
Nursing Diagnoses: Ethnocultural, 63
5 Gene Therapy and Pharmacogenomics, 67
Overview, 68
Basic Principles of Genetic Inheritance, 68
Discovery, Structure, and Function of DNA, 69
Gene Therapy, 70
Pharmacogenetics and Pharmacogenomics, 71
Application of Genetic Principles as a Result of Drug
Therapy and the Nursing Process, 72
6 Medication Errors: Preventing and Responding, 75
General Impact of Errors on Patients, 75
Medication Errors, 76
Issues Contributing to Errors, 78
8
9
10
Preventing, Responding to, Reporting, and Documenting
Medication Errors: A Nursing Perspective, 80
Other Ethical Issues, 83
Summary, 84
Patient Education and Drug Therapy, 88
Overview, 88
Assessment of Learning Needs Regarding Drug
Therapy, 89
Nursing Diagnoses Regarding Learning Needs and
Drug Therapy, 91
Planning Regarding Learning Needs and Drug Therapy, 91
Implementation Regarding Drug Therapy, 91
Evaluation of Patient Learning Regarding Drug
Therapy, 94
Over-the-Counter Drugs and Natural Health Products, 98
Over-the-Counter Drugs, 98
Natural Health Products, 101
Assessment, 105
Nursing Diagnoses, 106
Planning, 106
Implementation, 107
Evaluation, 107
Vitamins and Minerals, 111
Overview, 112
Assessment, 127
Nursing Diagnoses, 128
Planning,128
Implementation, 128
Evaluation, 129
Principles of Drug Administration, 133
Preparing For Drug Administration, 133
Enteral Drugs, 135
Parenteral Drugs, 141
Topical Drugs, 157
PART 2 Drugs Affecting the Central Nervous
System
11 Analgesic Drugs, 164
Overview, 166
Treatment of Pain in Special Situations, 170
Opioid Drugs, 172
Nonopioid and Miscellaneous Analgesics, 180
Assessment, 184
Patient Teaching Tips, 193
12 General and Local Anaesthetics, 195
Overview, 196
General Anaesthetics, 196
Drugs for Procedural Sedation, 200
Local Anaesthetics, 200
Neuromuscular Blocking Drugs, 203
Interactions, 205
Dosages, 205
xv
xvi
13
14
15
16
CONTENTS
Pharmacokinetic Bridge to Nursing Practice, 207
Assessment, 207
Nursing Diagnoses, 209
Planning, 209
Implementation, 209
Evaluation, 211
Central Nervous System Depressants and Muscle
Relaxants, 214
Overview, 215
Physiology of Sleep, 215
Benzodiazepines and Miscellaneous Hypnotic Drugs, 215
Barbiturates, 218
Over-the-Counter Hypnotics, 220
Muscle Relaxants, 220
Assessment, 222
Nursing Diagnoses, 223
Planning, 223
Implementation, 224
Evaluation, 225
Central Nervous System Stimulants and Related Drugs, 228
Overview, 228
Attention Deficit Hyperactivity Disorder, 229
Narcolepsy, 229
Obesity, 230
Migraine, 230
Drugs for Attention Deficit Hyperactivity Disorder and
Narcolepsy, 230
Adverse Effects, 232
Anorexiants, 235
Antimigraine Drugs, 235
Analeptics, 236
Assessment, 237
Nursing Diagnoses, 238
Planning, 238
Implementation, 239
Evaluation, 240
Antiepileptic Drugs, 244
Epilepsy, 245
Antiepileptic Drugs, 246
Assessment, 254
Nursing Diagnoses, 257
Planning, 257
Implementation, 258
Evaluation, 259
Antiparkinsonian Drugs, 262
Parkinson’s Disease, 263
Treatment of Parkinson’s Disease, 264
Drug Therapy, 264
Dopamine Replacement Drugs, 266
Indirect-Acting Dopaminergic Drugs, 267
Dopamine Modulator, 269
Catechol Ortho-Methyltransferase Inhibitors, 270
Anticholinergic Therapy, 270
Assessment, 271
Nursing Diagnoses, 273
Planning, 273
Implementation, 274
Evaluation, 275
17 Psychotherapeutic Drugs, 278
Overview, 279
Overview of Mental Health Disorders, 280
Anxiety Disorders, 281
Affective Disorders, 284
Mood-Stabilizing Drugs, 284
Antidepressant Drugs, 285
Tricyclic Antidepressants, 287
Monoamine Oxidase Inhibitors, 289
Second-Generation Antidepressants, 291
Psychotic Disorders, 293
Assessment, 298
Nursing Diagnoses, 301
Planning, 301
Implementation, 302
Evaluation, 304
18 Substance Misuse, 308
Overview, 309
Opioids, 309
Stimulants, 311
Depressants, 312
Alcohol, 314
Nicotine, 316
Assessment, 318
Nursing, Diagnoses, 321
Planning, 321
Implementation, 322
Evaluation, 322
PART 3 Drugs Affecting the Autonomic Nervous
System
19 Adrenergic Drugs, 325
Overview, 326
Sympathetic Nervous System, 326
Adrenergic Drugs, 327
Assessment, 333
Nursing Diagnoses, 333
Planning, 334
Implementation, 334
Evaluation, 336
20 Adrenergic-Blocking Drugs, 338
Overview, 339
Assessment, 345
Nursing Diagnoses, 346
Planning, 346
Implementation, 346
Evaluation, 347
21 Cholinergic Drugs, 350
Overview, 350
Parasympathetic Nervous
System, 350
Cholinergic Drugs, 351
Assessment, 355
Nursing Diagnoses, 355
Planning, 356
Implementation, 356
Evaluation, 358
CONTENTS
22 Cholinergic-Blocking Drugs, 361
Overview, 361
Assessment, 366
Nursing Diagnoses, 367
Planning, 367
Implementation, 368
Evaluation, 368
27
PART 4 Drugs Affecting the Cardiovascular and
Renal Systems
23 Antihypertensive Drugs, 371
Overview, 372
Antihypertensive Drugs, 374
Review of Autonomic Neurotransmission, 375
Diuretics, 375
Adrenergic Drugs, 376
Angiotensin-Converting Enzyme Inhibitors, 379
Angiotensin II Receptor Blockers, 382
Calcium Channel Blockers, 383
Vasodilators, 383
Assessment, 386
Nursing Diagnoses, 387
Planning, 387
Implementation, 388
Evaluation, 390
24 Antianginal Drugs, 394
Overview, 394
Antianginal Drugs, 395
Beta Blockers, 398
Calcium Channel Blockers, 400
Summary of Antianginal Pharmacology, 401
Pharmacokinetic Bridge to Nursing Practice, 401
Assessment, 402
Nursing Diagnoses, 402
Planning, 402
Implementation, 403
Evaluation, 404
25 Heart Failure Drugs, 408
Overview, 408
Drug Therapy, 410
Angiotensin-Converting Enzyme Inhibitors, 411
Angiotensin II Receptor Blockers, 411
Beta Blockers, 411
Aldosterone Antagonists, 412
Omega-3 Polyunsaturated Fatty Acids, 412
Phosphodiesterase Inhibitors, 412
Cardiac Glycosides, 413
Assessment, 417
Nursing Diagnoses, 418
Planning, 418
Implementation, 419
Evaluation, 420
26 Antidysrhythmic Drugs, 423
Dysrhythmias and Normal Cardiac Electrophysiology, 424
Antidysrhythmic Drugs, 430
Assessment, 437
28
29
30
xvii
Pharmacokinetic Bridge to Nursing Practice, 438
Nursing Diagnoses, 438
Planning, 438
Implementation, 439
Evaluation, 440
Coagulation Modifier Drugs, 444
Hemostasis and Coagulation, 445
Coagulation Modifier Drugs, 447
Assessment, 460
Nursing Diagnoses, 463
Planning, 463
Implementation, 464
Evaluation, 466
Antilipemic Drugs, 469
Overview, 469
Lipids and Lipid Abnormalities, 470
Atherosclerotic Plaque Formation, 471
Cholesterol and Coronary Artery Disease, 471
Dyslipidemias and Treatment Guidelines, 472
Hydroxymethylglutaryl–Coenzyme A Reductase
Inhibitors, 473
Bile Acid Sequestrants, 476
Nicotinic Acid, 477
Fibric Acid Derivatives, 478
Assessment, 479
Nursing Diagnoses 480
Planning, 480
Implementation, 481
Evaluation, 482
Diuretic Drugs, 485
Overview, 486
Diuretic Drugs, 486
Carbonic Anhydrase Inhibitors, 487
Loop Diuretics, 488
Summary of Major Drug Effects of Loop Diuretics, 488
Osmotic Diuretics, 489
Potassium-Sparing Diuretics, 490
Thiazides and Thiazide-Like Diuretics, 493
Assessment, 494
Nursing Diagnoses, 495
Planning, 495
Implementation, 496
Evaluation, 497
Fluids and Electrolytes, 500
Overview, 501
Physiology of Fluid Balance, 501
Crystalloids, 502
Colloids, 504
Blood Products, 506
Physiology of Electrolyte Balance, 507
Potassium, 507
Sodium, 509
Assessment, 511
Nursing Diagnoses, 513
Planning, 513
Implementation, 513
Evaluation, 515
xviii
CONTENTS
PART 5 Drugs Affecting the Endocrine System
31 Pituitary Drugs, 519
Endocrine System, 519
Pituitary Drugs, 520
Assessment, 523
Nursing Diagnoses, 525
Planning, 525
Implementation, 525
Evaluation, 525
32 Thyroid and Antithyroid Drugs, 528
Thyroid Function, 528
Hypothyroidism, 529
Hyperthyroidism, 529
Thyroid Replacement Drugs, 529
Antithyroid Drugs, 531
Pharmacokinetic Bridge to Nursing Practice, 532
Assessment, 532
Nursing Diagnoses, 533
Planning, 533
Implementation, 534
Evaluation, 534
33 Antidiabetic Drugs, 537
Pancreas, 538
Diabetes, 539
Antidiabetic Drugs, 543
Injectable Antihyperglycemic Drugs, 552
Assessment, 554
Nursing Diagnoses, 555
Planning, 556
Implementation, 556
Evaluation, 559
34 Adrenal Drugs, 563
Adrenal System, 563
Adrenal Drugs, 565
Assessment, 569
Nursing Diagnoses, 569
Planning, 569
Implementation, 570
Evaluation, 571
35 Women’s Health Drugs, 574
Overview of Female Reproductive Functions, 575
Female Sex Hormones, 576
Drugs Related to Pregnancy, Labour, Delivery, and the
Postpartum Period, 585
Assessment, 589
Nursing Diagnoses, 591
Planning, 591
Implementation, 591
Evaluation, 592
36 Men’s Health Drugs, 596
Overview of the Male Reproductive System, 596
Androgens and Other Drugs Pertaining to Men’s
Health, 597
Pharmacokinetic Bridge to Nursing Practice, 600
Assessment, 601
Nursing Diagnoses, 601
Planning, 602
Implementation, 602
Evaluation, 603
PART 6 Drugs Affecting the Respiratory
System
37 Antihistamines, Decongestants, Antitussives, and
Expectorants, 606
Cold Medications, 607
Antihistamines, 608
Decongestants, 612
Antitussives, 613
Expectorants, 615
Assessment, 616
Nursing Diagnoses, 617
Planning, 617
Implementation, 617
Evaluation, 618
38 Respiratory Drugs, 621
Overview, 621
Diseases of the Respiratory System, 622
Treatment of Diseases of the Lower Respiratory
Tract, 624
Bronchodilators, 624
Nonbronchodilating Respiratory
Drugs, 629
Assessment, 632
Nursing Diagnoses, 634
Planning, 634
Implementation, 635
Evaluation, 636
PART 7 Drugs Affecting the Gastrointestinal
System and Nutrition
39 Acid-Controlling Drugs, 640
Overview, 640
Hydrochloric Acid, 640
Antacids, 643
H2 Antagonists, 644
Proton Pump Inhibitors, 646
Miscellaneous Acid-Controlling Drugs, 648
Assessment, 649
Nursing Diagnoses, 650
Planning, 650
Implementation, 650
Evaluation, 651
40 Antidiarrheal Drugs and Laxatives, 654
Overview 654
Antidiarrheals, 655
Laxatives, 657
Assessment, 663
Nursing Diagnoses, 663
Planning, 663
CONTENTS
Implementation, 664
Evaluation, 664
41 Antiemetic and Antinausea Drugs, 667
Nausea and Vomiting, 667
Antiemetic and Antinausea Drugs, 667
Assessment, 673
Nursing Diagnoses, 675
Planning, 675
Implementation, 675
Evaluation, 676
42 Nutritional Supplements, 679
Overview, 680
Enteral Nutrition, 680
Total Parenteral Nutrition, 683
Assessment, 686
Nursing Diagnoses, 686
Planning, 686
Implementation, 686
Evaluation, 688
46
47
48
PART 8 Anti-infective and Anti-inflammatory Drugs
43 Antibiotics Part 1: Sulfonamides, Penicillins,
Cephalosporins, Macrolides, and Tetracyclines, 691
Microbial Infection, 692
General Principles of Antibiotic Therapy, 694
Sulfonamides, 697
Penicillins, 698
Cephalosporins, 702
Assessment, 709
Nursing Diagnoses, 710
Planning, 710
Implementation, 711
Evaluation, 711
44 Antibiotics Part 2: Aminoglycosides, Fluoroquinolones,
and Other Drugs, 715
Overview, 716
Aminoglycosides, 716
Quinolones, 719
Assessment, 725
Nursing Diagnoses, 726
Planning, 727
Implementation, 727
Evaluation, 728
45 Antiviral Drugs, 731
General Principles of Virology, 732
Overview of Viral Illnesses and Their Treatment, 733
Herpes Simplex Virus and Varicella-Zoster Virus
Infections, 735
Antivirals (Non-HIV), 736
HIV Infection and AIDS, 739
Drugs Used to Treat HIV Infection, 742
Other Viral Illnesses, 745
Assessment, 747
Nursing Diagnoses, 748
Planning, 748
49
xix
Implementation, 748
Evaluation, 750
Antitubercular Drugs, 753
Tuberculosis, 753
Antitubercular Drugs, 754
Assessment, 758
Nursing Diagnoses, 759
Planning, 759
Implementation, 760
Evaluation, 761
Antifungal Drugs, 764
Fungal Infections, 764
Antifungal Drugs, 765
Assessment, 770
Nursing Diagnoses, 770
Planning, 770
Implementation, 770
Evaluation, 771
Antimalarial, Antiprotozoal, and Anthelmintic Drugs, 774
Overview, 774
Malaria, 774
Antimalarial Drugs, 775
Other Protozoal Infections, 780
Nonmalarial Antiprotozoal Drugs, 780
Helminthic Infections, 783
Anthelmintic Drugs, 783
Assessment, 784
Nursing Diagnoses, 785
Planning, 785
Implementation, 785
Evaluation, 786
Anti-inflammatory and Antigout Drugs, 789
Overview, 789
Nonsteroidal Anti-Inflammatory Drugs, 790
Antigout Drugs, 796
Assessment, 798
Nursing Diagnoses, 799
Planning, 799
Implementation, 800
Evaluation, 801
PART 9 Immune and Biological Modifiers and
Chemotherapeutic Drugs
50 Immunosuppressant Drugs, 804
Immune System, 804
Immunosuppressant Drugs, 805
Assessment, 810
Nursing Process, 811
Planning, 811
Implementation, 811
Evaluation, 812
51 Immunizing Drugs and Pandemic Preparedness, 815
Immunity and Immunization, 816
Immunizing Drugs, 819
Pandemic Preparedness and Response, 826
xx
CONTENTS
Assessment, 826
Nursing Diagnoses, 828
Planning, 828
Evaluation, 829
52 Antineoplastic Drugs Part 1: Cancer Overview and Cell
Cycle–Specific Drugs: 832
Overview, 833
Cell Cycle–Specific Antineoplastic Drugs, 841
Assessment, 849
Nursing Diagnoses, 852
Planning, 852
Implementation, 852
Evaluation, 855
53 Antineoplastic Drugs Part 2: Cell Cycle–Nonspecific and
Miscellaneous Drugs, 859
Cell Cycle–Nonspecific Antineoplastic Drugs, 859
Miscellaneous Antineoplastics, 864
Hormonal Antineoplastics, 865
Radiopharmaceuticals and Related Antineoplastics, 865
Assessment, 866
Nursing Diagnoses, 868
Planning, 868
Implementation, 868
Evaluation, 870
54 Biological Response–Modifying Drugs and Antirheumatic
Drugs, 872
Overview of Immunomodulators, 874
Immune System, 874
Biological Response Modifiers, 875
Hematopoietic Drugs, 875
Interferons, 877
Monoclonal Antibodies, 879
Interleukins and Related Drugs, 883
Miscellaneous Immunomodulating Drugs, 884
Rheumatoid Arthritis, 885
Disease-Modifying Antirheumatic Arthritis Drugs, 885
Assessment, 887
Nursing Diagnoses, 888
Planning, 888
Implementation, 888
Evaluation, 889
PART 10 Miscellaneous Therapeutics:
Hematological, Dermatological,
Ophthalmic, and Otic Drugs
55 Anemia Drugs, 892
Erythropoiesis, 892
Types of Anemia, 893
Erythropoiesis-Stimulating Agents, 895
Iron, 895
Folic Acid, 897
Other Anemia Drugs, 899
Assessment, 899
Pharmacokinetic Bridge To Nursing Practice, 899
Nursing Diagnoses, 899
Planning, 899
Implementation, 900
Evaluation, 900
56 Dermatological Drugs, 903
Skin Anatomy and Physiology, 904
Topical Dermatological Drugs, 904
Antimicrobials, 905
General Antibacterial Drugs, 906
Antiacne Drugs, 907
Antifungal Drugs, 908
Antiviral Drugs, 909
Topical Anaesthetics, 910
Topical Antipruritics and Anti-Inflammatories, 910
Antipsoriatic Drugs, 910
Miscellaneous Dermatological Drugs, 911
Wound Care Drugs, 913
Skin Preparation Drugs, 913
Assessment, 914
Nursing Diagnoses, 914
Planning, 914
Implementation, 915
Evaluation, 915
57 Ophthalmic Drugs, 918
Ocular Anatomy and Physiology, 919
Treatment of Eye Disorders, 921
Glaucoma, 922
Antiglaucoma Drugs, 922
Antimicrobial Drugs, 929
Anti-Inflammatory Drugs, 931
Topical Anaesthetics, 933
Diagnostic Drugs, 933
Antiallergic Drugs, 934
Assessment, 934
Nursing Diagnoses, 935
Planning, 935
Implementation, 935
Evaluation, 935
58 Otic Drugs, 939
Overview of Ear Anatomy, 939
Treatment of Ear Disorders, 940
Antibacterial and Antifungal Otic Drugs, 940
Assessment, 942
Nursing Diagnoses, 942
Planning, 942
Implementation, 942
Evaluation, 942
Appendix: Pharmaceutical Abbreviations, 945
Answers to Review Questions, 946
Bibliography, 949
Index of Glossary Terms, 966
Drug Index, 973
General Index, 981
PART 1 Pharmacology Basics
1
Nursing Practice in Canada
and Drug Therapy
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. List the five phases of the nursing process.
2. Identify the components of the assessment process for
patients receiving medications, including the collection and
analysis of subjective and objective data.
3. Discuss the process of formulating nursing diagnoses for
patients receiving medications.
4. Identify goals and outcome criteria for patients receiving
medications.
5. Discuss the evaluation process involved in the
administration of medications and reflected in the goals and
outcome criteria.
6. Develop a collaborative plan of care using the nursing
process and the principles of medication administration.
7. List and briefly discuss the Ten Rights associated with safe
medication administration.
8. Discuss the professional responsibility and standards
of practice for the professional nurse as a result of the
medication administration process.
KEY TERMS
Adherence Active, voluntary, and collaborative involvement
of the patient in the mutually acceptable, prescribed course
of treatment or therapeutic plan. (p. 3)
Critical thinking The ability to reason and think rationally in
order to understand, solve problems, and make decisions; a
major component of the nursing process, often considered
the foundation on which to provide the best possible patient
care, supported by current best evidence. (p. 2)
Evidence-informed practice (EIP) Continuous, interactive
process involving the explicit, conscious, and judicious
consideration of the best research evidence available to make
collaborative decisions between the health care team and the
patient and family when providing patient care. (p. 11)
Goals Statements that are time-specific and describe generally
what must be accomplished to address a specific nursing
diagnosis. (p. 2)
OVERVIEW
The nursing practice environment in Canada is increasingly
demanding, due in part to the increased acuity and complexity
of patient care and the aging population. Nurses are expected
to keep up to date with the rising use of intricate pharmacological therapies, including natural health products and over-thecounter drugs. In addition to rising costs, other factors such as
Medication error Any preventable adverse drug event
involving inappropriate medication use by a patient or
health care provider. (p. 10)
Nonadherence An informed decision by a patient not to adhere
to or follow a therapeutic plan or suggestion. (p. 4)
Nursing process An organizational framework for the practice
of nursing that encompasses all steps taken by the nurse in
caring for a patient: assessment, nursing diagnoses, planning
(with goals and outcome criteria), implementation of the
plan (with patient teaching), and evaluation. (p. 2)
Outcome criteria Descriptions of specific patient behaviours
or responses that demonstrate the meeting or achievement
of goals related to each nursing diagnosis. (p. 6)
Prescriber Any health care provider licensed by the appropriate
regulatory body to prescribe medications. (p. 4 )
professional shortages, advances in treatment modalities, and
new technologies continue to challenge the health care system.
In such an environment, knowledge of drugs, their adverse
effects, and their interactions is crucial for nurses to provide
safe, ethical, competent care. Nurses are expected to be more
accountable, with increased attention focused on safe medication practices. Evaluating and promoting therapeutic effects,
1
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PART 1 Pharmacology Basics
as well as reducing the harm associated with adverse effects,
adverse interactions, and drug toxicity, and making decisions
about prn (pro re nata or “as needed”) medications require
excellent critical thinking and decision-making skills.
The nursing process is a well-established, research-supported framework for professional nursing practice. It is a flexible, adaptable, and adjustable five-step process consisting of
assessment, nursing diagnoses, planning (including establishment of goals and outcome criteria), implementation (including patient education), and evaluation. As such, the nursing
process ensures the delivery of thorough, individualized, and
quality nursing care to patients. Through use of the nursing
process combined with knowledge and skills, the professional
nurse can develop effective solutions to meet patients’ needs.
The use of the nursing process is one way to organize nursing
care and may be viewed as controversial in some educational
and health care institutions that use other decision-making
frameworks. Some view the nursing process as a repetitive tool
developed prior to the technology era that may assist in developing an initial plan of care but is limited in assisting to make
the detailed judgements and decision making required today.
Others view it as the foundation of problem solving and believe
it fits well with evidence-informed practice. However, it is still
considered the major systematic framework for professional
nursing practice.
Usually, the nursing process is discussed within nursing
courses and in textbooks on the fundamentals of nursing practice, nursing theory, physical assessment, adult and pediatric
nursing, and other nursing specialty areas. Because the nursing
process is so important in the care of patients, the process in all
its five phases, along with evidence-informed practice examples,
will be included in each chapter of this book as they relate to
specific drug groups and classifications.
Critical thinking is one part of the nursing process and
is often considered the foundation on which to provide the
best possible patient care, supported by current best practice.
Clinical reasoning, a more specific term, and clinical judgement
are key components of critical thinking in nursing. Clinical reasoning refers to the way nurses analyze and understand patient
care issues such as determining, preventing, and managing
patient problems. A nurse who is proficient at clinical reasoning
will be able to make timely and effective patient-centred decisions. Sound clinical reasoning is essential for preserving the
standards of the nursing profession and promoting good patient
outcomes. Clinical reasoning involves applying ideas to experience in order to arrive at a valid clinical judgement.
The elements of the nursing process address the physical,
emotional, spiritual, sexual, financial, cultural, and cognitive
aspects of a patient. Attention to these many aspects allows a
more holistic approach to patient care. For example, a cardiologist may focus on cardiac functioning and pathology, a physiotherapist on movement, and a chaplain on the spiritual aspects
of patient care. However, it is the professional nurse who thinks
critically about processes, incorporates all of these aspects and
points of information about the patient, and then uses this
information to develop and coordinate patient care. Therefore,
the nursing process remains a central process and framework
for nursing care. Box 1.1 provides guidelines for nursing care
planning related to drug therapy and the nursing process.
ASSESSMENT
During the initial assessment phase of the nursing process,
data are collected, reviewed, and analyzed. Performing a comprehensive assessment allows the nurse to formulate a nursing
diagnosis related to the patient’s needs—for the purposes of
this textbook, specifically needs related to pharmacotherapy,
of which one aspect is drug administration. Information about
the patient may come from a variety of sources, including the
patient; the patient’s family, caregiver, or significant other; and
the patient’s chart. Methods of data collection include interviewing, direct and indirect questioning, observation, medical
records review, head-to-toe physical examination, and nursing
assessment. Data are categorized into objective and subjective
data.
Subjective data include information obtained through a
nursing history and shared through the spoken word by any
reliable source, such as the patient, the spouse, another family
member, a significant other, or a caregiver.
Objective data may be defined as any information gathered through the senses or that which is seen, heard, felt, or
smelled. Objective data may also be obtained from a nursing
physical assessment; past and present medical history; results
of laboratory tests, diagnostic studies, or procedures; measurement of vital signs, weight, and height; and medication profile.
Medication profiles include, but are not limited to, the following
information: any and all drug use; use of home or folk remedies and natural health products or homeopathic treatments;
intake of alcohol, tobacco, and caffeine; current or past history
of illicit drug use; use of over-the-counter (OTC) medications
(e.g., aspirin, acetaminophen, vitamins, laxatives, cold preparations, sinus medications, antacids, acid reducers, antidiarrheals,
minerals, chemical elements); use of hormonal drugs (e.g., testosterone, estrogens, progestins, oral contraceptives); past and
present health history and associated drug regimen(s); family
history and racial, ethnic, or cultural attributes with attention
to specific or different responses to medications as well as any
unusual individual responses; and growth and developmental
stage (e.g., Erikson’s developmental tasks) and issues related to
the patient’s age and medication regimen. A holistic nursing
assessment includes gathering of data about the whole individual, including physical and emotional realms, religious preference, health beliefs, sociocultural characteristics, race, ethnicity,
lifestyle, stressors, socioeconomic status, education level, motor
skills, cognitive ability, support systems, lifestyle, and use of any
complementary and alternative therapies.
Assessment related to specific drugs is also important and
involves the collection of specific information about prescribed,
OTC, and natural health products or complementary and alternative therapeutic drug use, with attention to the drug’s actions;
signs and symptoms of allergic reaction; adverse effects; dosages and routes of administration; contraindications; drug
incompatibilities; drug–drug, drug–food, and drug–laboratory test interactions; and toxicities and available antidotes.
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
BOX 1.1
3
Guidelines for Nursing Care Planning
The sample in this study presents useful information for developing a nursing
process–focused care plan for patients receiving medications. Brief listings and
discussions of what must be contained in each phase of the nursing process are
included. This sample may be used as a template for formatting nursing care
plans in a variety of patient care situations or settings.
Assessment
Subjective Data
Subjective data include all spoken information shared by the patient as part
of taking a nursing history, such as concerns, problems, or stated needs (e.g.,
patient reports “dizziness, headache, vomiting, and feeling hot for 10 days”).
Objective Data
Objective data include information available through the senses, that is, what is
seen, felt, heard, and smelled. Among the sources of data are the chart, laboratory test results, reports of diagnostic procedures, physical assessment results,
and examination findings. Examples of specific data are age, height, weight,
allergies, medication profile, and health history.
Nursing Diagnoses
Once the assessment phase has been completed, the nurse analyzes subjective
and objective data about the patient and the drug and formulates nursing diagnoses. The following is an example of a nursing diagnosis statement: “Deficient
knowledge related to lack of experience with medication regimen and Grade 2
reading level as an adult, as evidenced by inability to perform a return demonstration and inability to state adverse effects to report to the prescriber.” This statement of the nursing diagnosis can be broken down into three parts, as follows:
• Part 1: “Deficient knowledge.” This is the statement of the human response
of the patient to illness, injury, medications, or significant change. This can
be an actual response, an increased risk, or an opportunity to improve the
patient’s health status. The nursing diagnosis related to knowledge may be
identified as either inadequate or ready for enhanced (knowledge).
• Part 2: “Related to lack of experience with medication regimen and Grade
2 reading level as an adult.” This portion of the statement identifies factors
related to the response; often it includes multiple factors with some degree
of connection between them. The nursing diagnosis statement does not necessarily claim that there is a cause-and-effect link between these factors and
the response, only that there is a connection.
• Part 3: “As evidenced by inability to perform a return demonstration and
inability to state adverse effects to report to the prescriber.” This statement
Nursing pharmacology textbooks provide a more nursing-specific knowledge base regarding drug therapy as a result of the
nursing process. Use of current references or those dated within
the last 3 years is highly recommended. Examples of authoritative resources include the Compendium of Pharmaceuticals and
Specialties (CPS; a subscription-based e-CPS is also available
online), the drug manufacturer’s insert, drug handbooks, and
a licensed pharmacist. Some reliable online resources include
Health Canada’s Drug Product Database (http://www.hc-sc.
gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php) and
the Objective Comparisons for Optimal Drug Therapy (http://
www.rxfiles.ca/).Other online resources are cited throughout
this textbook.
Gather additional data about the patient and a given drug
by asking yourself these simple questions: What is the patient’s
oral intake? Tolerance of fluids? Swallowing ability for pills,
tablets, capsules, and liquids? If there is difficulty swallowing,
lists clues, cues, evidence, or data that support the nurse’s claim that the
nursing diagnosis is accurate.
Nursing diagnoses are prioritized in order of criticality, based on patient
needs or problems. The ABCs of care (airway, breathing, and circulation) are
often used as a basis for prioritization. Prioritizing always begins with the
most important, significant, or critical need of the patient. Nursing diagnoses
that involve actual responses are always ranked above nursing diagnoses that
involve only risks.
Planning: Goals and Expected Patient Outcome Criteria
The planning phase includes the identification of short-term and long-term
goals and outcome criteria, provides time frames, and is patient oriented. Goals
are objective, realistic, and measurable patient-centred statements with time
frames and are broad, whereas outcome criteria are more specific descriptions
of patient goals.
Implementation
In the implementation phase, the nurse intervenes on behalf of the patient to
address specific patient problems and needs. This is done through independent
nursing actions; collaborative activities such as physiotherapy, occupational
therapy, and music therapy; and implementation of medical orders. Family, significant others, and caregivers assist in carrying out this phase of the nursing
care plan. Specific interventions that relate to particular drugs (e.g., giving a
particular cardiac drug only after monitoring the patient’s pulse and blood pressure), nonpharmacological interventions that enhance the therapeutic effects of
medications, and patient education are major components of the implementation
phase. See the previous text discussion of the nursing process for more information on nursing interventions.
Evaluation
Evaluation is the part of the nursing process that includes monitoring whether
patient goals and outcome criteria related to the nursing diagnoses are met.
Monitoring includes observing for therapeutic effects of drug treatment as
well as for adverse effects and toxicity. Many indicators are used to monitor
these aspects of drug therapy as well as the results of appropriately related
nonpharmacological interventions. If the goals and outcome criteria are met,
the nursing care plan may or may not be revised to include new nursing diagnoses; such changes are made only if appropriate. If goals and outcome criteria
are not met, revisions are made to the entire nursing care plan with further
evaluation.
what is the degree of difficulty and are there solutions to the
problem, such as the use of thickening agents with fluids or the
use of other dosage forms? What are the results of laboratory
and other diagnostic tests related to organ functioning and drug
therapy? What do kidney function studies (e.g., urea nitrogen,
creatinine) show? What are the results of liver function tests
(e.g., total protein, bilirubin, alkaline phosphatase, creatinine
phosphokinase, other liver enzymes)? What are the patient’s
white blood cell and red blood cell counts? Hemoglobin and
hematocrit levels? Current as well as past health status and presence of illness? What are the patient’s experiences with use of
any drug regimen? What has been the patient’s relationship with
health care providers or experiences with previous therapeutic
regimens? What are current and past values for blood pressure,
pulse rate, temperature, and respiratory rate? What medications
is the patient currently taking, and how is the patient taking
and tolerating them? Are there issues with adherence (implying
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PART 1 Pharmacology Basics
collaboration and an active role between patients and their
health care providers)? Has there been any use of traditional or
folk medicines or remedies? What is the patient’s understanding of the medication? Are there any age-related concerns? If
patients are not reliable historians, family members, significant
others, or caregivers may provide answers to these questions.
Once assessment of the patient and the drug has been completed, the specific prescription or medication order (from any
prescriber) must be checked for the following six elements: (1)
patient’s name, (2) date the drug order was written, (3) name
of drug(s), (4) drug dosage amount and frequency, (5) route of
administration, and (6) prescriber’s signature.
It is also important during the assessment to consider the
traditional, nontraditional, expanded, and collaborative roles of
the nurse. Physicians and dentists are no longer the only practitioners legally able to prescribe and write medication orders.
Registered nurses do not order medications; they follow standard orders established by physicians. In some cases, depending
on agency and provincial or territorial regulatory body, registered nurses can administer medications without a physician’s
order (e.g., registered nurses with an additional “certified practice”), according to agency-specific protocols, such as pyrexia
protocols or bowel protocols, or certain classifications of drugs.
In some provinces (e.g., Ontario, British Columbia, Alberta),
the scope of practice for registered nurses was expanded to allow
nurses the authority to dispense certain medications under certain circumstances. Dispensing involves preparing and transferring a medication for a patient or the patient’s representative to
be administered at a later date—for example, if a patient has a
day pass and requires medication while absent or if a client is discharged from the emergency department and requires medication
to be started. Dispensing entails ensuring that the medication is
pharmaceutically and therapeutically appropriate for the intended
use and that it will be used properly. It may also include accepting
payment for a medication on behalf of a nurse’s employer.
Nurse practitioners and physician assistants have the professional privilege of legally prescribing medications. As of 2016, in
Canada, there are 400 physician assistants (PAs), who support
physicians in a variety of health care settings. The role for PAs
began in Canada within the Canadian Forces Health Services
50 years ago, and physician assistants now practise in Manitoba,
New Brunswick, Ontario, and Alberta. Physician assistants are
meant to extend the role of the physician; they work under
the supervision of physicians and are not independent practitioners. In Manitoba and New Brunswick, PAs are regulated
through their respective College of Physicians and Surgeons;
in Ontario and Alberta, PAs practise by delegation under the
Medicine Act and the Medical Act, respectively. PAs are autonomous decision makers and perform a range of diagnostic and
therapeutic services, including writing prescriptions. PAs must
complete a two-year educational program that is accredited by
the Canadian Medical Association (2019). Nurse practitioners
(NPs) are registered nurses with an advanced degree who
practise in the Extended Class. They have extra education and
experience and are legally competent to diagnose, order, and
interpret diagnostic tests; prescribe medications; and perform
procedures.
ANALYSIS OF DATA
Once data about the patient and drug have been collected and
reviewed, critically analyze and synthesize the information.
Verify all information and document appropriately. It is at this
point that the sum of the information about the patient and
drug is used in the development of nursing diagnoses.
CASE STUDY
The Nursing Process and Pharmacology
Katie, a 27-year-old teacher, is visiting the clinic
today for a physical examination. She states that
she and her husband want to “start a family,” but
she has not had a physical for several years. She
was told when she was 22 years of age that she
had “anemia” and was given iron tablets but states
that she has not taken them for years. She said she
“felt better” and did not think she needed them. She
denies any use of tobacco or illegal drugs; she states
that she may have a drink with dinner once or twice
a month. She uses tea tree oil on her face twice a
day to reduce acne breakouts. She denies using any other drugs.
1. During the physical assessment, what other questions does the nurse need
to ask?
2. After laboratory work is performed, Katie is told she is slightly anemic. The
prescriber recommends that she resume taking iron supplements as well as
folic acid. She is willing to try again and says that she is “all about doing
what’s right to stay healthy and become a mother.” What nursing diagnoses would be appropriate at this time?
3. Katie is given a prescription that reads as follows: “ferrous fumarate 300
mg, PO for anemia.” When she goes to the pharmacy, the pharmacist tells
her that the prescription is incomplete. What is missing? What should be
done?
4. After 4 weeks, Katie’s latest laboratory results indicate that she still has
anemia. However, Katie states, “I feel so much better that I’m planning to
stop taking the iron tablets. I hate to take medicine.” How should the nurse
handle this?
For answers, see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
NURSING DIAGNOSES
Nursing diagnoses are developed by professional nurses and are
used as a means of communicating and sharing information
about the patient and the patient experience. Nursing diagnoses
are the result of critical thinking, creativity, and analysis of the
data collected about the patient and the drug. They are clinical
judgements about how a person responds to health conditions
and life processes or vulnerability for that response. Nursing
diagnoses related to drug therapy will most likely develop out of
data associated with the following: inadequate knowledge; risk of
injury; nonadherence; various disturbances, deficits, excesses, or
impairments in bodily functions; and other problems or concerns
as a result of drug therapy. The development and classification of
nursing diagnoses has been carried out by NANDA International
(NANDA-I) (formerly North American Nursing Diagnosis
Association [NANDA]). NANDA-I is the formal organization
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
recognized by professional nursing groups (e.g., the Canadian
Nurses Association [CNA] and the American Nurses Association)
(NANDA International, 2014). NANDA-I is considered the major
contributor to the development of nursing knowledge and the
leading authority in the development and classification of nursing diagnoses. The purpose of NANDA-I is to increase the visibility of nursing’s contribution to the care of patients and to
further develop, refine, and classify the information and phenomena related to nurses and professional nursing practice. The use
of a standardized language of nursing diagnoses documents the
analysis, synthesis, and accuracy required in making a nursing
diagnosis and establishes nursing’s contribution to cost-effective,
efficient, quality health care. See Box 1.2 for more information
about the 2015–2017 NANDA-I–approved nursing diagnoses.
A Brief Look at NANDA and the
Nursing Process
BOX 1.2
NANDA International (NANDA-I) (formerly known as the North American
Nursing Diagnosis Association International) fulfills the following roles: (1)
increases the visibility of nursing’s contribution to patient care, (2) develops,
refines, and classifies information and phenomena related to professional
nursing practice, (3) provides a working organization for the development of
evidence-informed nursing diagnoses, and (4) supports the improvement of
quality nursing care through evidence-informed practice and access to a global
network of professional nurses. In 1987, NANDA and the American Nurses
Association endorsed a framework for establishing nursing diagnoses, and
in 1990, Nursing Diagnoses became the official journal of NANDA. In 2001
and 2003, NANDA modified and updated the listing of nursing diagnoses,
but nursing diagnoses continued to be submitted for consideration by the ad
hoc research committee of NANDA. This period resulted in changes such as
replacement of the phrase risk for with potential for. The terms impaired, deficient, ineffective, decreased, increased, and imbalanced replaced the outdated
terms altered and alteration, although the outdated terms may still be in use.
In 2002, NANDA changed its name to NANDA-I (“I” for international) to
reflect the organization’s global reach. Every 2 years, revisions are made to
the nursing diagnoses, adding new and revised nursing diagnoses as well as
retiring outdated ones. Most current is the Nursing Diagnoses 2015–2017:
Definitions and Classifications, which provides more “linguistically congruent
diagnoses” (Herdman & Kamitsuru, 2014). The guide includes a total of 235
diagnoses supported by definitions, defining characteristics, related factors,
and risk factors. There are 26 new diagnoses and 13 revised diagnoses, based
on global evidence. Seven diagnoses were removed. Changes were made to
some of the definitions of nursing diagnoses, which impacted the risk and
health promotion diagnoses. The word risk was removed from “risk” diagnoses and replaced with vulnerable; the health promotion diagnoses were
altered to ensure that they are suitable for use across the health–illness continuum. Defining characteristics also were altered.
There are 13 domains (spheres of knowledge) of diagnoses that are further
divided into 47 classes (groupings that share common attributes). The new
diagnoses include 14 vulnerable diagnoses, one health promotion diagnosis,
and 11 problem-focused diagnoses, in the area of: (1) cardiovascular function;
(2) elimination; (3) emancipated decision making; (4) frailty in the elderly; (5)
mobility; (6) mood and emotional regulation; (7) nutrition; (8) pain; (9) skin/
tissue/mucous membrane function; (10) surgical recovery; and (11) thermoregulation. These domains are further divided into classes.
Herdman, T. H., & Kamitsuru, S. (2014). In NANDA international nursing diagnoses: Definitions & classification, 2015–2017. Used by arrangement with Wiley Blackwell.
5
More recently, a long-term project of the International
Council of Nurses (ICN) to provide a unified language system was initiated. The International Classification for Nursing
Practice (ICNP) is a framework that can be cross-mapped with
other health care classification systems such as NANDA to create
multidisciplinary health vocabularies or lexicons within information systems (International Council of Nurses, 2014). The
overall intent is that nursing diagnoses, nursing interventions,
and nursing outcomes within the ICNP would be used in health
care record documentation. The CNA has endorsed the ICNP
as the standard for collecting nursing data. The objectives of
the ICNP are as follows: (1) to establish a common language for
describing nursing practice in order to improve communication
among nurses and between nurses and others; (2) to describe
the nursing care of people (individuals, families, and communities) in a variety of settings, both institutional and noninstitutional; (3) to enable comparison of nursing data across clinical
populations, settings, geographic areas, and time; (4) to demonstrate or project trends in the provision of nursing treatments
and care and the allocation of resources to patients according to
their needs, based on nursing diagnoses; (5) to stimulate nursing
research through links to data available in nursing information
systems and health information systems; and (6) to provide data
about nursing practice in order to influence health policy-making. “ICNP seeks to cover nursing diagnoses (which may also be
used to represent nursing outcomes) and nursing interventions
in entirety, accepting that this is a formative process and that
nursing covers a broad range of health care and is not a clearly
bounded discipline” (International Classification for Nursing
Practice, 2017). There is a disparity in opinion across Canada
about whether NANDA diagnoses, patient problems (actual or
potential), nursing priorities, diagnostic reasoning, or clinical
impression identification is the better approach.
Formulation of nursing diagnoses is usually a three-step
process, with nursing diagnoses stated as follows: Part I of the
statement is the human response of the patient to illness, injury,
or significant change. This response can be an actual problem,
an increased risk of developing a problem, or an opportunity or
intent to increase the patient’s health. Part II of the nursing diagnosis statement identifies the factor(s) related to the response,
with often more than one factor named. The nursing diagnosis statement does not necessarily claim a cause-and-effect link
between these factors and the response; it indicates only that
there is a connection between them. Part III of the nursing
diagnosis statement contains a listing of clues, cues, evidence,
or other data that support the nurse’s claim that this diagnosis
is accurate. Tips for writing a nursing diagnosis include the following: begin with a statement of a human response; connect
Part I of the statement or the human response with Part II—the
cause—using the phrase related to; ensure that Parts I and II are
not restatements of one another; include several factors in Part
II of the statement, such as associated factors, if appropriate;
select a cause for Part II of the statement that can be changed
by nursing interventions; avoid negative wording or language;
and, finally, list clues or cues that led to the nursing diagnosis in
Part III of the statement, which may also include more defining
characteristics (e.g., “as evidenced by”).
6
PART 1 Pharmacology Basics
The diagnoses most relevant to drug therapy will be used
in this textbook. These nursing diagnoses, as well as all other
phases of the nursing process, will be presented in the chapters
to follow because of the framework of practice that the nursing
process provides to all professional nurses; they are also used to
organize the nursing sections of this textbook.
PLANNING
After data are collected and nursing diagnoses formulated, the
planning phase begins; this phase includes identification of goals
and outcome criteria. The major purposes of the planning phase
are to prioritize the nursing diagnoses and specify goals and outcome criteria, including the time frame for their achievement.
The planning phase provides time to obtain special equipment
for interventions, review the possible procedures or techniques
to be used, and gather information either for oneself (the nurse)
or for the patient. This step leads to the provision of safe care
if professional judgement is combined with the acquisition of
knowledge about the patient and the medications to be given.
Goals and Expected Patient Outcome Criteria
Goals are objective, measurable, and realistic, with an established time period for achievement of the outcomes, which are
specifically stated in the outcome criteria. Patient goals reflect
expected and measurable changes in behaviour through nursing
care and are developed in collaboration with the patient. Patient
goals developed in the planning phase of the nursing process are
behaviour based and may be categorized into physiological, psychological, spiritual, sexual, cognitive, motor, or other domains.
Outcome criteria are concrete descriptions of patient
goals. They are patient focused, succinct, and well thought out.
Outcome criteria also include expectations of behaviour indicating something that can be changed and with a specific time
frame or deadline. The ultimate aim of these criteria is the safe
and effective administration of medications. Outcome criteria
also reflect each nursing diagnosis and serve as a guide to the
implementation phase of the nursing process. Formulation of
outcome criteria begins with the analysis of the judgements
made about patient data and subsequent nursing diagnoses and
ends with the development of a nursing care plan. Outcome
criteria provide a standard for measuring movement toward
goals. In regard to medication administration, these outcomes
may address special storage and handling techniques, administration procedures, equipment needed, drug interactions,
adverse effects, and contraindications. In this textbook, specific time frames generally are not provided in each chapter’s
nursing process section because every patient care situation is
individualized.
IMPLEMENTATION
Implementation is guided by the preceding phases of the nursing process (i.e., assessment, nursing diagnoses, and planning).
Implementation requires constant communication and collaboration with the patient and members of the health care team
involved in the patient’s care, as well as any family members,
significant other, or other caregivers. Implementation consists
of initiation and completion of specific nursing actions by the
nurse, as defined by nursing diagnoses, goals, and outcome
criteria. Nursing interventions or actions may be independent, collaborative, or dependent upon a prescriber’s order.
Statements of interventions include frequency, specific instructions, and any other pertinent information. With medication
administration, the nurse needs to know and understand all
the information about the patient and about each medication
prescribed (see assessment questions on p. 2). Implementation
is based on the nurse’s clinical judgement and knowledge. It
also is important for the nurse to recognize that patients differ
significantly in their attitude toward taking medications. The
principles of informed consent and choice should underpin
medication administration. It is critical for the nurse to explain
the benefits and risks of a treatment in a way that the patient can
grasp. Once patients understand the potential benefits and risks
of therapy, they can make meaningful decisions.
Nurses are also advocates for all marginalized patients who
face a diversity of issues related to equitable treatment and allocation of resources surrounding medications. Vulnerable and
marginalized patients face lack of drug coverage, the inability
to pay for prescriptions, and a multitude of other barriers that
require health care providers to provide facilitation and timely
responses.
Nurses must also adhere to safe administration practices to
prevent errors. Traditionally, in years past, nurses adhered to the
Five Rights of medication administration: right drug, right dose,
right time, right route, and right patient. However, these rights
have been expanded to Ten Rights (summarized in Box 1.3).
The Ten Rights are discussed in detail in the next sections of this
chapter. The “rights” of medication administration have been
identified as basic standards of care as a result of drug therapy.
Nurses are required to practise under their provincial or territorial regulatory body’s standards and agency policy, and these
may vary. However, even the implementation of the Ten Rights
does not reflect the complexity of the role of the professional
nurse because they focus more on the individual patient than
on the system as a whole or the entire medication administration process, beginning with the prescriber’s order. Viewed from
an individual patient focus, additional rights (or entitlements)
must be considered when administering medications. These
rights include the following:
• Patient safety, ensured by use of the correct procedures,
equipment, and techniques of medication administration
and documentation
• Individualized, holistic, accurate, and complete patient education
• Double-checking and constant analysis of the system (i.e.,
the process of drug administration, including all personnel
involved, such as the prescriber, the nurse, the nursing unit,
and the pharmacy department, as well as patient education)
• Proper drug storage
• Accurate calculation and preparation of the dose of medication and proper use of all types of medication delivery systems
• Careful checking of the transcription of medication orders
• Accurate use of the various routes of administration and
awareness of the specific implications of their use
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
BOX 1.3 Ten Rights of Medication
Administration
1. Right Drug (or Right Medication): Ensuring that the drug to be administered is the right medication that was ordered.
2. Right Dose: Ensuring that the dose ordered is correct for the patient’s age
and body parameters, and questioning doses that do not seem correct or
are outside the patient’s usual dose range.
3. Right Time: Ensuring that the drug is administered at the time ordered, at
the right frequency, and according to institutional policy.
4. Right Route: Ensuring that the drug is administered by the route ordered
as well as verifying that the route is safe and appropriate for the patient.
5. Right Patient: Ensuring that the drug is being administered to the patient
it was intended for, by checking the drug order information against the
patient’s identification band.
6. Right Reason: Ensuring that the drug ordered is being given for the right
reason, thus necessitating prior knowledge of the drug’s actions and
adverse effects.
7. Right Documentation: Ensuring that documentation of the medication
administration is done after the drug has been administered, not before;
moreover, ensuring that any unusual variances in time, dose, and drug
reactions are properly recorded, as well as if the patient has refused the
drug.
8. Right Evaluation (or Right Assessment): Ensuring that any special assessment requirements have been made prior to the drug administration, such
as specific pulse rate and blood pressure readings and laboratory results;
moreover, ensuring that appropriate monitoring of the patient has been
done following drug administration and that follow-up measures are
taken if the drug has not achieved its desired effect.
9. Right Patient Education: Ensuring that the patient has been given proper
explanation of the drug being given, the reason for its administration,
and what to expect in terms of the drug’s effects and possible adverse
effects.
10. Right to Refuse: Ensuring that the patient understands his right to refuse
the drug being administered and to be informed of the potential consequences of refusal.
• Close consideration of special situations (e.g., patient difficulty in swallowing, use of a nasogastric tube, unconsciousness of the patient, advanced patient age)
• Implementation of all appropriate measures to prevent and
report medication errors
Right Drug
Administration of the right drug begins with the registered
nurse’s valid licence to practise. Unregulated care providers
(UCPs) may also assist with medication administration. Nurses
may teach UCPs medication administration and documentation, but the nurse remains ultimately accountable for the
process of medication administration. The registered nurse is
responsible for checking all medication orders or prescriptions.
Prepouring a medication and not administering it at the time
of pouring, or having another nurse or student administer it,
increases the risk of errors and confuses the line of accountability for the preparation of the medication. It is the nurse’s
responsibility and best practice to prepare medications as close
as possible to the time they are to be administered, watch the
patient take the medication, and not allow another individual
to administer a medication for the nurse and sign it off. (NOTE:
there are rare exceptions to this best practice, such as preloading
7
syringes for a mass immunization program or an urgent need
for drugs during a cardiac arrest.) To ensure that the correct
drug is given, the nurse must check the specific medication
order against the medication label or profile three times before
giving the medication. Conduct the first check of the right drug,
drug name, and drug expiration date while preparing the medication for administration. At this time, consider whether the
drug is appropriate for the patient and, if you are in doubt or
believe an error is possible, contact the prescriber or pharmacist immediately (see Evidence in Practice box on this page).
Safety huddles are held on most acute care units, often with a
pharmacist, to discuss new medications, changes to practice, or
ways to manage errors. Usually a pharmacist is assigned to each
unit to be available to answer questions. It is also appropriate
at this time to note the drug’s indication and be aware that a
drug may have multiple indications, including off-label use and
non–Health Canada-approved indications. In this textbook,
each particular drug is discussed in the chapter that deals with
its main indication, but drugs with multiple uses may also be
cross-referenced in other chapters.
EVIDENCE IN PRACTICE
Patient Safety: Examining the Adequacy of the
Five Rights of Medication Administration
Review
Patient safety is of utmost importance in health care today. For decades, the
Five Rights (right drug, right patient, right dose, right route, right time) of medication administration have been the standard for safe medication practices;
they are taught routinely in educational settings and implemented in practice.
The Five Rights were found to be lacking because of the focus on individual
performance and the failure to include individual factors and system deficiencies. Patients are no longer passive recipients of care and are choosing to play
increasingly greater roles in the process of care.
Type of Evidence and Results of the Study
Martyn, Paliadelis, and Perry (2019) conducted an appreciative inquiry qualitative study to understand registered nurses’ experiences of medication administration using the Five Rights. In total, 20 inpatient medical/surgical registered
nurses participated in the study. The researchers found that although in most
instances, participants displayed inconsistent use of the Five Rights, they did
implement other strategies such as organization and patient-centred care
to ensure improved patient safety when administering medication. Findings
opened new conversations around the linear process encouraged by the Five
Rights framework that do not consider the complex environment of contemporary health care settings.
Link of Evidence to Nursing Practice
The Five Rights are no longer sufficient for safe administration of medication.
In most provinces, nursing associations recommend that seven or ten rights be
used, which includes a medication history and assessment, interpretation of
assessment data, anticipating risks, providing patient education, and planning
for evaluation of medication effectiveness as well as observing for potential
interactions with other medications, food, or natural health products. Each of
these clinical judgement actions requires vigilance and clinical reasoning but
it is important to refer to provincial nursing (RN/LPN) association and health
care institution recommendations. Medication administration is a complex,
interrelated process involving many players and steps. Collaboration among
all players, including the patient, caregiver, and family, is essential to safe,
ethical, and competent care.
8
PART 1 Pharmacology Basics
All medication orders or prescriptions are required by law
to be signed by the prescriber involved in the patient’s care. If a
verbal order is given, the prescriber must sign the order within
24 hours or as per facility protocol. Verbal, telephone, or texting
orders are often used in emergencies and time-sensitive patient
care situations. Preprinted orders based on current evidence
may also be available under certain circumstances. To be sure
that the right drug is given, information about the patient and
drug (see previous discussion of the assessment phase) must be
obtained to make certain that all variables and data have been
considered. Approved, current, authoritative references (see
earlier discussion) are the reliable sources of information about
prescribed drugs. Avoid relying upon the knowledge of peers as
this is unsafe nursing practice. Remain current in your knowledge of generic (nonproprietary) drug names as well as trade
names (proprietary name that is registered by a specific drug
manufacturer); however, in clinical practice, only the drug’s
generic name is used, to reduce the risk of medication errors.
A single drug often has numerous trade names, and drugs in
different classes may have similarly spelled names, increasing
the possibility of medication errors (see Preventing Medication
Errors box). Therefore, when it comes to the “right drug” phase
of the medication administration process, use the drug’s generic
name to help avoid a medication error and enhance patient
safety. (See Chapter 2 for more information on the naming of
drugs.)
If there are questions about a medication order at any time
during the medication administration process, contact the prescriber for clarification. Never make any assumptions when it
comes to drug administration, and, as previously emphasized
in this chapter, confirm at least three times the right drug, right
dose, right time, right route, right patient, and right reason—
when removing the drug from the patient drawer or cabinet,
when pouring the drug, and in many instances at the bedside,
with the third check involving an identifier from the patient
(this may not be required by all agencies), before giving the
medication. You must adhere to the Ten Rights of medication
administration according to the provincial or territorial regulatory body under which you are practising. With the increasing use of technology (e.g., texting, fax, email, cellphones) in
health care to make communication between health care providers more “timely” and cost efficient, it is important to caution
the nurse about the risks involved. Recommendations for use
of wireless technology include protected security features (e.g.,
data encryption, password protection, device swiping). There
may be specific agency policies for the transmission of patient
information and documentation of the medical information
or order transmitted, as well as procedures for the information
becoming part of the permanent health record.
Right Dose
Whenever a medication is ordered, a dosage is identified from
the prescriber’s order. Always check the dose and confirm that
it is appropriate to the patient’s age and size. Check appropriate
laboratory and diagnostic results such as potassium, creatinine,
and ammonia levels. Also, check the prescribed dose against
the available drug stocks and against the normal dosage range.
Recheck all mathematical calculations, and pay careful attention to decimal points, the misplacement of which could lead
to a tenfold or even greater overdose. Leading zeros, or zeros
placed before a decimal point, are allowed, but in numbers less
than 1, trailing zeros, or zeros following the decimal point, are
to be avoided. For example, 0.2 mg is allowed but 2.0 milligrams
is not acceptable because it could easily be mistaken for 20 mg,
especially with unclear penmanship. Patient variables (e.g.,
vital signs, age, sex, weight, height) require careful assessment
because of the need for dosage adjustments in response to specific parameters. Children and older adult patients are more
sensitive to medications than younger and middle-age adult
patients; thus, use extra caution with drug dosage amounts for
these patients.
PREVENTING MEDICATION ERRORS
Right Dose?
The nurse is reviewing the orders for a newly admitted patient. One order
reads: “Acetaminophen, 2 tablets PO, every 4 hours as needed for pain or
fever.”
The pharmacist calls to clarify this order, saying, “The dose is not clear.”
What does the pharmacist mean by this? The order says “2 tablets.” Isn’t that
the dose?
NO! If you look up acetaminophen in a drug resource book, you will see that
acetaminophen tablets are available in strengths of both 325 mg and 500 mg.
The order is missing the “right dose” and needs to be clarified. Never assume
the dose of a medication order.
Right Time
Each health care agency or institution has a policy regarding
routine medication administration times; therefore, always
check this policy. However, when giving a medication at the
prescribed time, the nurse may be confronted with a conflict
between the timing suggested by the physician and specific
pharmacokinetic and pharmacodynamic (see Chapter 2) drug
properties, concurrent drug therapy, dietary influences, laboratory or diagnostic testing, and specific patient variables. For
example, the prescribed right time for administration of antihypertensive drugs may be four times a day, but for an active,
professional 42-year-old male patient working 13 to 14 hours a
day, taking a medication four times a day may not be feasible,
and this regimen may lead to nonadherence and subsequent
complications. Appropriate actions include contacting the
prescriber and inquiring about the possibility of prescribing
another drug with a different dosing frequency (e.g., once or
twice daily).
For routine medication orders, nurses have long adhered to
medication administration according to the 30-minute rule:
no more than 30 minutes before or after the actual time specified in the prescriber’s orders (i.e., if a medication is ordered
to be given at 0900 hours every morning, the medication may
be given anytime between 0830 and 0930 hours). According to
the Institute for Safe Medication Practices (Institute for Safe
Medication Practices Canada, 2011), such rigid rules lead to
nurses taking shortcuts and subsequently making errors. The
ISMP points out that “a one-size-fits-all, inflexible requirement
9
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
p.m.
Recommended Guidelines for
Timely Administration of Medications
BOX 1.4
Type of Scheduled
Medication
2400
2300
Goals for Timely
Administration
Time-Critical Scheduled Medications
Facility-defined time-critical medica- Administer at the exact time indicated
tions*
when necessary (e.g., rapid-acting
Including but not limited to medicainsulin); otherwise within 30 mintions with a dosing schedule more
utes before or after the scheduled
frequent than every 4 hours
time.
Non–Time-Critical Scheduled Medications
Daily, weekly, monthly medications
Administer within 2 hours before or
after the scheduled time.
Medications prescribed more
Administer within 1 hour before or
frequently than daily, but no more
after the scheduled time.
frequently than every 4 hours
*Limited number of drugs where delayed or early administration of
more than the 30 minutes may cause harm or subtherapeutic effect.
Adapted from Institute for Safe Medication Practices. (2011). Guidelines for timely medication administration: Response to the CMS
‘30-minute rule.’ Retrieved from http://www.ismp.org/newsletters/acutecare/articles/20110113.asp. Used with permission from the Institute
for Safe Medication Practices.
to administer all scheduled medications within 30 minutes of
the scheduled time is a precarious mandate, given that relatively
few medications truly require exact timing of doses.” The ISMP
has recommended guidelines for the timely administration of
drugs (see Box 1.4).
Medications designated to be given stat (immediately) must
be administered within 30 minutes of the time the order is
written. Assess and follow the hospital or facility policy and
procedure for any other specific information concerning the
30-minutes-before-or-after rule. For medication orders with the
annotation prn, the medication must be given at special times
and under certain circumstances. For example, for an analgesic
ordered every 4 hours prn for pain, after one dose of the medication, the patient reports pain. After assessment, intervention
with another dose of analgesic would occur, but only 4 hours
after the previous dose. In addition, because of the increasing
incidence of medication errors related to the use of abbreviations, many prescribers are using the wording as required or as
needed instead of the abbreviation prn. Military time is used
when medication and other orders are written into a patient’s
chart (Fig. 1.1).
Nursing judgement may lead to some variations in timing,
and the nurse must document any change and the rationale
for the change. If medications are ordered to be given once
every day, twice daily, three times daily, or even four times
daily, the times of administration may be changed if doing so
is not harmful to the patient and if the medication or patient’s
condition does not require adherence to an exact schedule,
but only if the change is approved by the prescriber. Never
underestimate the effect of a change in the dosing or timing
of medication because one missed dose of certain medications
can be life threatening. Other factors must be considered in
determining the right time, such as multiple-drug therapy,
11
2200
1100
10
12
1200
a.m.
1300
1
0100
0200
1000
2100 9 0900
2000
8
2
1400
0300 3 1500
0400
0800
0700
7
1900
4
1600
0500
0600
6
5
1700
1800
Fig. 1.1 The 24-hour clock. (From Sorrentino, S. A., & Remmert, L. N.
(2012). Mosby’s textbook for nursing assistants (8th ed.). p. 69, Fig. 6-6.
St Louis, MO: Mosby.)
drug–drug or drug–food compatibility, scheduling of diagnostic tests, bioavailability of the drug (e.g., the need for consistent timing of doses around the clock to maintain blood
levels), drug actions, and any biorhythm effects such as those
that occur with steroids. It is also critical to patient safety to
avoid using abbreviations for any component of a drug order
(i.e., dose, time, and route).
Right Route
As previously stated, the nurse must know the particulars about
each medication before administering it to ensure that the right
drug, dose, and route are being used. A complete medication
order includes the route for administration. If a medication
order does not include the route, the nurse must ask the prescriber to clarify it. Never assume the route of administration.
Right Patient
Checking the patient’s identity before giving each medication
dose is critical to the patient’s safety. Ask the patient to state his
or her own name and then check the patient’s identification band
to confirm the patient’s name, identification number, age, and
allergies. With children, the parents or legal guardians are often
the ones who identify the patient for the purposes of administration of prescribed medications. With newborns and labour
and delivery situations, the mother and baby have identification bracelets with matching numbers, which must be checked
before giving medications. With older adults or patients with
altered sensorium or level of consciousness, asking them to state
their names is neither realistic nor safe. Therefore, checking the
identification band against the medication profile, medication
order, or other treatment or service orders is crucial to avoid
errors. Accreditation Canada (2019) has required organizational
practices to improve the quality and safety of health services.
10
PART 1 Pharmacology Basics
One practice is to use at least two identifiers before providing
care, treatment, or services to patients. Accreditation Canada
identifies that the information obtained must be specific to the
patient. Examples include a person-specific identification number such as a registration number; patient identification cards
such as the health card with name, address, and date of birth;
patient barcodes; double witnessing; or a patient wristband. The
two identifiers may be in the same location, such as on a wristband. The patient’s room number is not an acceptable identifier.
Right Reason
The nurse must ensure that the drug is being given for the right
reason and clarify any medication orders that do not seem to fit
within a right reason. When uncertain, always check the CPS or
contact the pharmacy or prescriber for clarification. If the nurse
administers an unfamiliar drug and remains unknowledgeable
about its action and intended effect, the drug may cause harm,
although unintended, to the patient. Sometimes a medication
may be administered for a reason that is not obvious, as the classification is not the reason for the administration. For example,
lactulose, although classified as a laxative, is also used for the
treatment of hepatic encephalopathy to bind with ammonia to
reduce toxic levels.
Right Documentation
Documentation of information related to medication administration is crucial to patient safety. Recording patient observations and nursing actions has always been an important ethical
responsibility, but it has become a major medical–legal consideration as well. Because of its significance in professional nursing practice, correct documentation is becoming known as the
“sixth right” of medication administration. Always assess the
patient’s chart for the presence of the following information:
date and time of medication administration, name of medication, dose, route, and site of administration. Documentation of
drug action may also be performed in the regularly scheduled
assessments for any changes in symptoms the patient is experiencing, adverse effects, toxicity, and any other drug-related,
physical or psychological symptoms.
Documentation must also reflect any improvement in the
patient’s condition, symptoms, or disease process as well as
whether there has been no change or a lack of improvement.
Not only must you document these observations, but you must
also report them to the prescriber promptly, in keeping with
your critical thinking and judgement. Document any teaching,
as well as an assessment of the degree of understanding exhibited by the patient. Other information that needs documentation includes the following:
1. If a drug is not administered, with the reason why and any
actions taken
2. Refusal of a medication with information about the reason
for refusal, if possible. If a medication is refused, respect the
patient’s right (to refuse), determine the reason by assessing
the patient’s knowledge level as it pertains to refusing the
drug, and document. Take appropriate action, including notifying the prescriber, and revise the nursing care plan. Never
return unwrapped medication to a container and discard
according to agency policy; if wrapper remains intact, return
medication to the pharmacy and revise the nursing care plan
as needed.
3. Actual time of drug administration
4. Data regarding clinical observations and treatment of the
patient if a medication error has occurred
If there has been a medication error, complete an incident
report with the entire event, surrounding circumstances, therapeutic response, adverse effects, and notification of the prescriber described in detail. However, do not record completion
of an incident report in the medical chart. Always follow specific individual agency policies/protocols regarding medication
errors and incident reporting.
Most provinces and territories are using or are moving to
implement electronic health records. The electronic health
record (EHR) is a collection of the personal health information of a patient that is stored electronically and kept under
strict security. This information is accessible online from
many separate, interoperable automated systems within an
electronic network. It provides an online profile of a patient’s
drug prescription history. The system also informs of drug
interactions.
Medication Errors
When the “rights” of drug administration are discussed, medication errors must be considered. Medication errors are a
major problem for all in health care, regardless of the setting.
The National Coordinating Council for Medication Error
Reporting and Prevention (2019) defines a medication error
as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in
the control of the health care professional, patient, or consumer.
Such events may be related to professional practice, health care
products, procedures, or systems, including prescribing, order
communication, product labelling, packaging, and nomenclature, compounding, dispensing, distribution, administration,
education, monitoring, and use” (https://www.nccmerp.org/
about-medication-errors). Both patient-related and system-related factors must always be considered when the medication
administration process and the prevention of medication errors
are being examined. See Chapter 6 for further discussion of
medication errors and their prevention.
EVALUATION
Evaluation occurs after the collaborative plan of care has been
implemented. It is a systematic, ongoing, and dynamic part of
the nursing process as a result of drug therapy. It includes monitoring the fulfillment of goals and outcome criteria, as well as
the patient’s therapeutic response to the drug and its adverse
effects and toxic effects. Documentation is also an important
component of evaluation. The move to EHRs and computer
workstations that are located in patient rooms or wherever care
is provided enables nurses to document point-of-care and realtime charting. Documentation must be accurate and present a
clear and comprehensive picture of the patient’s outcome criteria (see Legal & Ethical Principles box).
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
LEGAL & ETHICAL PRINCIPLES
Nursing Documentation: Use of Technology
In many agencies, the transition to technology carries compelling implications
for the nursing profession and the health care system. With the use of electronic health systems, handwriting is no longer needed, thus producing more
legible and comprehensive patient records. Technology can take many forms,
for example, computerized records, emails, faxes, texts, cellphones, tablets,
and recordings. The use of technology carries a higher risk of breach of confidentiality. Nurses have an ethical responsibility to safeguard information
obtained in the nurse–patient relationship. Therefore, certain precautions are
required to protect privacy and maintain confidentiality:
• Do not disclose or allow access to any personal identification number or
password. These are electronic signatures.
• Select a password that cannot be easily deciphered.
• Log off the system when you are not using it or when leaving the screen, to
secure the computer and files.
• Protect patient data shown on screens with the use of a screen saver or
“sleep,” with the location of the device, or with the use of privacy screens.
• Maintain confidentiality of all electronic data, including print copies of any
data.
• Make sure that all discarded print data that contains patient information is
shredded.
• Access patient information only if it is essential to provide nursing care for
that patient; doing so for purposes other than providing nursing care is a
breach of confidentiality.
Source: College of Nurses of Ontario. (2017). Confidentiality and
privacy—Personal health information. Retrieved from http://www.cno.
org/Global/docs/prac/41069_privacy.pdf; College of Registered Nurses
of British Columbia. (2013). Practice standard. Nursing documentation.
Retrieved from https://www.crnbc.ca/standards/lists/standardresources/151nursingdocumentation.pdf.
Evaluation also includes monitoring the implementation of
standards for nursing practice. Several standards are in place to
help in the evaluation of outcomes of care, such as those established by nursing provincial and territorial governing bodies
and the Canadian Council on Health Services Accreditation
(CCHSA). Within the CCHSA, guidelines are established
11
for nursing services, policies, and procedures. The Canadian
Nurses Association Code of Ethics (2017) and the Canadian
Council for Practical Nurse Regulators (CCPNR) Code of Ethics
for Licensed Practical Nurses (2013), as well as specific provincial/territory medication practice standards are also used in
establishing and evaluating standards of care.
EVIDENCE-INFORMED PRACTICE
In this information era, nurses encounter a plethora of health
conditions and possible treatments, which include pharmacotherapeutics. In order to stay informed and current,
evidence-informed practice (EIP), also referred to as evidence-based practice, has emerged in the past 10 years as the
“gold standard” for using current, valid, and relevant information when making clinical decisions. When applying EIP,
results include more accurate diagnoses, effective and efficient interventions, and improved patient outcomes. Evidence
derived from systematic reviews of randomized clinical trials
(RCTs) is often considered the strongest level of evidence;
however, descriptive and qualitative studies as well as expert
opinions may be considered when making decisions. The
development of clinical practice guidelines based on scientific evidence helps to integrate the best research evidence
into practice. Within this textbook, Evidence in Practice boxes
will be used to identify current, clinically relevant research
evidence about specific prescription drugs as well as natural
health products.
In summary, the nursing process is an ongoing and constantly
evolving process (see Box 1.1). As it relates to drug therapy, the
nursing process is the way in which the nurse gathers, analyzes,
organizes, provides, and acts upon data about the patient within
the context of prudent nursing care and standards of care. The
nurse’s ability to conduct astute assessments, formulate sound
nursing diagnoses, establish goals and outcome criteria, correctly administer drugs, and continually evaluate patients’
responses to drugs increases with additional experience and
knowledge.
KEY POINTS
• The nursing process is an ongoing, constantly changing, and
evolving framework for professional nursing practice. It may
be applied to all facets of nursing care, including medication
administration.
• The phases of the nursing process include assessment; development of nursing diagnoses; planning, with establishment
of goals and outcome criteria; implementation, including
patient education; and evaluation.
• Nursing diagnoses are formulated based on objective and
subjective data and help to drive the nursing care plan. Nursing diagnoses have been developed through a formal process,
including NANDA-I and the International Classification for
Nursing Practice, and are constantly updated and revised.
Safe, therapeutic, and effective medication administration is
a major responsibility of professional nurses as they apply the
nursing process to the care of their patients.
• Nurses are responsible for safe and prudent decision making in the nursing care of their patients, including the provision of drug therapy; in accomplishing this task, they attend
to the Ten Rights and adhere to legal and ethical standards
related to medication administration and documentation.
There are additional rights related to drug administration.
These rights deserve worthy consideration before initiation
of the medication administration process. Observance of all
these rights enhances patient safety and helps avoid medication errors.
12
PART 1 Pharmacology Basics
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. An 86-year-old patient is being discharged to home on
digoxin and has little information regarding the medication.
Which statement best reflects a realistic outcome of patient
teaching activities?
a. The patient and patient’s daughter will state the proper
way to take the drug.
b. The nurse will provide teaching about the drug’s adverse
effects.
c. The patient will state all the symptoms of digoxin toxicity.
d. The patient will call the prescriber if adverse effects occur.
2. A patient has a new prescription for a blood pressure medication that may cause him to feel dizzy during the first few
days of therapy. Which is the best nursing diagnosis for this
situation?
a. Activity intolerance
b. Potential for injury
c. Disturbed body image
d. Self-care deficit
3. A patient’s chart includes an order that reads as follows:
digoxin 0.025 mcg once daily at 0900 hours. Which action by
the nurse is correct?
a. The nurse gives the drug via the transdermal route.
b. The nurse gives the drug orally.
c. The nurse gives the drug intravenously.
d. The nurse contacts the prescriber to clarify the dosage
route.
4. The nurse is compiling a drug history for a patient. Which
question from the nurse will obtain the most information
from the patient?
a. “Do you depend on sleeping pills to get to sleep?”
b. “Do you have a family history of heart disease?”
c. “When you have pain, what do you do to relieve it?
d. “What childhood diseases did you have?”
5. A 77-year-old man who has been diagnosed with an upper
respiratory infection tells the nurse that he is allergic to penicillin. What is the most appropriate response by the nurse?
a. “That is to be expected—lots of people are allergic to penicillin.”
b. “This allergy is not of major concern because the drug is
given so commonly.”
c. “What type of reaction did you have when you took penicillin?”
d. “Drug allergies don’t usually occur in older individuals
because they have built up resistance.”
6. The nurse is preparing a care plan for a patient who has been
newly diagnosed with type 2 diabetes mellitus. Put into correct order the steps of the nursing process, with 1 being the
first step and 5 being the last step.
a. Implementation
b. Planning
c. Assessment
d. Evaluation
e. Nursing diagnoses
7. The nurse is reviewing new medication orders that have been
written for a newly admitted patient. Which orders will the
nurse need to clarify? Select all that apply.
a. Metformin (Glucophage®) 1000 mg PO twice a day
b. Sitagliptin (Januvia®) 50 mg daily
c. Simvastatin (Zocor®) 20 mg PO every evening
d. Irbesartan (Avapro®) 300 mg PO once a day
e. Docusate (Colace®) as needed for constipation
8. The nurse is reviewing data collected from a medication
history. Which of these data are considered objective data?
(Select all that apply.)
a. White blood cell count 22,000 mm3
b. Blood pressure 150/94 mm Hg
c. Patient rates pain as an “8” on a 10-point scale
d. Patient’s wife reports that the patient has been very sleepy
during the day
e. Patient’s weight is 150 lb
CRITICAL THINKING ACTIVITIES
1. What are the crucial responsibilities of the nurse when
implementing drug therapy?
2. When medications were administered during the night shift,
a patient refused to take his 0200 hours dose of an antibiotic,
claiming that he had just taken it. What actions by the nurse
would ensure sound decision making and maintain patient
safety?
3. During a busy shift, the nurse notes that the chart of a
newly admitted patient has a few orders for medications
and diagnostic tests that were taken by telephone by another
nurse. The nurse is on the way to the patient’s room to do
an assessment when the unit secretary says that one of the
orders reads as follows: “furosemide, 20 mg, stat.” What is the
priority action by the nurse? How does the nurse go about
giving this drug? Explain the best action to take in this situation.
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
•
•
•
•
Website
http://evolve.elsevier.com/Canada/Lilley/pharmacology/
• Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
CHAPTER 1 Nursing Practice in Canada and Drug Therapy
REFERENCES
Accreditation Canada. (2019). Required organizational practices.
version 14. Retrieved from http://www.wrha.mb.ca/quality/
files/2019ROPHandbook.pdf.
Canadian Council for Practical Nurse Regulators. (2013). Code of
ethics for licensed practical nurses in Canada. Retrieved from http://
www.ccpnr.ca/wp-content/uploads/2013/09/IJLPN-CE-Final.pdf.
Canadian Medical Association. (2019). PA education programs. Retrieved
from https://capa-acam.ca/pa-students/pa-education-programs/.
Canadian Nurses Association. (2017). Code of ethics for registered nurses. Retrieved from https://www.cna-aiic.ca/-/media/cna/page-content/pdf-en/code-of-ethics-2017-edition-secure-interactive.pdf.
Institute for Safe Medication Practices Canada. (2011). Guidelines for
timely medication administration; Response to the CMS “30-minute
rule.” Retrieved from http://www.ismp.org/newsletters/acutecare/
articles/20110113.asp.
13
International Classification for Nursing Practice. (2017). Technical
implementation guide. Retrieved from https://www.icn.ch/sites/
default/files/inline-files/ICNP_Technical_Implementation_Guide.
pdf.
International Council of Nurses. (2014). International classification for
nursing practice. Retrieved from http://www.icn.ch/what-we-do/
international-classification-for-nursing-practice-icnpr/.
Martyn, J. A., Paliadelis, P., & Perry, C. (2019). The safe administration of medication: Nursing behaviours beyond the five-rights.
Nurse Education in Practice, 37, 109–114. https://doi.org/10.1016/j.
nepr.2019.05.006.
NANDA International. (2014). Nursing diagnoses 2015–2017: Definitions and classification (10th ed.). Hoboken, NJ: Wiley.
National Coordinating Council for Medication Error Reporting
and Prevention. (2019). About medication errors. Retrieved from
https://www.nccmerp.org/about-medication-errors.
2
Pharmacological Principles
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Define common terms used in pharmacology (see Key
Terms).
2. Discuss the application of pharmaceutics,
pharmacokinetics, and pharmacodynamics in drug therapy.
3. Explain the properties of various drug dosage forms and
identify the advantages and disadvantages of the dose forms
and drug delivery systems used in drug therapy.
4. Discuss the relevance of the four facets of pharmacokinetics
(absorption, distribution, metabolism, excretion) to
5.
6.
7.
8.
professional nursing practice, as a result of drug therapy, for
a variety of patients and health care settings.
Discuss the use of natural drug sources in the development
of new drugs.
Describe evidence-informed nursing practice.
Discuss the role of evidence-informed practice as it relates
to pharmacology and medication administration.
Develop a collaborative plan of care that considers general
pharmacological principles in carrying out drug therapy.
KEY TERMS
Additive effects Drug interactions in which the effect of a
combination of two or more drugs with similar actions,
administered at the same time, is the action of one plus
the action of the other, with the total effect of both
drugs being given (compare with synergistic effects).
(p. 31)
Adverse drug event (ADE) Any undesirable occurrence as a
result of administering or failing to administer a prescribed
medication. (p. 31)
Adverse drug reaction (ADR) Any unexpected, unintended,
undesired, or excessive response to a medication given at
therapeutic dosages (compare with adverse drug event).
(p. 32)
Adverse effects A general term for any undesirable effects that
are a direct response to one or more drugs. (p. 30)
Agonists Drugs that bind to and stimulate the activity of one
or more receptors in the body. (p. 29)
Allergic reaction An immunological hypersensitivity reaction
resulting from the unusual sensitivity of a patient to a
medication; a type of adverse drug event. (p. 32)
Antagonists Drugs that bind to and inhibit the activity of
one or more receptors in the body; also called inhibitors.
(p. 29)
Antagonistic effects Drug interactions in which the effect of
a combination of two or more drugs is less than the sum of
the individual effects of the same drugs given alone; usually
caused by an antagonizing (blocking or reducing) effect of
one drug on another. (p. 31)
Bioavailability A measure of the fraction of drug
administered dose that is delivered unchanged to the
systemic circulation (from 0% to 100%). (p. 19)
14
Biotransformation One or more biochemical reactions
involving a parent drug. (p. 24)
Blood–brain barrier The barrier system that restricts the
passage of various chemicals and microscopic entities (e.g.,
bacteria, viruses) between the bloodstream and the central
nervous system but allows for the passage of essential
substances such as oxygen. (p. 24)
Chemical name The name that describes the chemical
composition and molecular structure of a drug. (p. 16)
Contraindication Any condition, especially one that is a
result of a disease state or patient characteristic, including
current or recent drug therapy, that renders a form of
treatment improper or undesirable. (p. 29)
Cytochrome P450 The general name for a large class of
enzymes that play a significant role in drug metabolism and
drug interactions. (p. 24)
Dependence A state in which there is a compulsive or chronic
need, as for a drug. (p. 30)
Dissolution The process by which solid forms of drugs
disintegrate in the gastrointestinal tract and become soluble
before they are absorbed into the circulation. (p. 17)
Drug Any chemical that affects the physiological processes of
a living organism. (p. 16)
Drug actions The processes involved in the interaction
between a drug and body cells (e.g., the action of a drug on
a receptor protein); also referred to as mechanisms of action.
(p. 17)
Drug classification A method of grouping drugs; may be
based on structure or therapeutic use. (p. 16)
Drug effects The physiological reactions of the body to a
drug. They can be therapeutic or toxic and describe how
CHAPTER 2 Pharmacological Principles
the body is affected by the drug. The terms onset, peak,
and duration are used to describe drug effects (most often
referring to therapeutic effects). (p. 27)
Drug-induced teratogenesis The development of congenital
anomalies or defects in the developing fetus that are caused
by the toxic effects of drugs. (p. 33)
Drug interaction Alteration of the pharmacological or
pharmacokinetic activity of a given drug caused by the
presence of one or more additional drugs; it is usually a
result of effects on the enzymes required for metabolism of
the involved drugs. (p. 31)
Duration of action The length of time the concentration
of a drug in the blood or tissues is sufficient to elicit a
therapeutic response. (p. 27)
Enzymes Protein molecules that catalyze one or more of
a variety of biochemical reactions, including those that
are a result of the body’s physiological processes or drug
metabolism. (p. 28)
First-pass effect The initial metabolism in the liver of a drug
absorbed from the gastrointestinal tract before the drug
reaches the systemic circulation through the bloodstream.
(p. 19)
Generic name The name given to a drug approved by Health
Canada; also called the nonproprietary name or the official
name. The generic name is much shorter and simpler than
the chemical name and is not protected by trademark.
(p. 16)
Glucose-6-phosphate dehydrogenase (G6PD) deficiency A
hereditary condition in which red blood cells break down
when the body is exposed to certain drugs. (p. 32)
Half-life In pharmacokinetics, the time it takes for the blood
level of a drug to be reduced by 50%; also called elimination
half-life. (p. 26)
Idiosyncratic reaction An abnormal and unexpected
response to a medication, other than an allergic reaction,
that is peculiar to an individual patient. (p. 32)
Incompatibility The characteristic that causes two parenteral
drugs or solutions to undergo a reaction when mixed or
given together that results in the chemical deterioration of
at least one of the drugs. (p. 31)
Intra-arterial Within an artery (e.g., intra-arterial injection).
(p. 23)
Intra-articular Within a joint (e.g., intra-articular injection).
(p. 23)
Intrathecal Within a sheath (e.g., the theca of the spinal cord),
as in an intrathecal injection into the subarachnoid space.
(p. 23)
Medication error (ME) Any preventable adverse drug event
involving inappropriate medication use by a patient or
health care provider; may or may not cause patient harm.
(p. 32)
Medication use process The prescribing, dispensing, and
administering of medications and the monitoring of their
effects. (p. 32)
Metabolite A chemical form of a drug that is the product
of one or more biochemical (metabolic) reactions
involving the parent drug. Active metabolites are those
15
that have pharmacological activity of their own, even
if the parent drug is inactive (see prodrug). Inactive
metabolites lack pharmacological activity and are simply
drug waste products awaiting excretion from the body
(e.g., via the urinary, gastrointestinal, or respiratory
tract). (p. 32)
Onset of action The time required for a drug to elicit a
therapeutic response after dosing. (p. 27)
Parent drug The chemical form of a drug that is administered
before it is metabolized by the body’s biochemical reactions
into its active or inactive metabolites. A parent drug that
is not pharmacologically active is called a prodrug. A
prodrug is then metabolized to pharmacologically active
metabolites. (p. 19)
Peak effect The time required for a drug to reach its
maximum therapeutic response in the body. (p. 27)
Peak level The maximum concentration of a drug in the body
after administration, usually measured in a blood sample
for therapeutic drug monitoring. (p. 28)
Pharmaceutics The science of preparing and dispensing
drugs, including dosage form design (e.g., tablets, capsules,
injections, patches, etc.). (p. 16)
Pharmacodynamics The study of the biochemical and
physiological interactions of drugs at their sites of activity; it
examines the properties of drugs and their pharmacological
interactions with body protein receptors. (p. 16)
Pharmacoeconomics The study of economic factors
impacting the cost of drug therapy. (p. 17)
Pharmacogenetics The study of the influence of genetic
factors on drug response, including the nature of genetic
aberrations that result in the absence, overabundance, or
insufficiency of drug-metabolizing enzymes (also called
pharmacogenomics; see Chapter 5). (p. 32)
Pharmacognosy The study of drugs that are obtained from
natural plant and animal sources. (p. 17)
Pharmacokinetics The study of drug absorption, distribution,
metabolism, and excretion (ADME) of drugs. (p. 17)
Pharmacology The broadest term for the study or science of
drugs. (p. 16)
Pharmacotherapeutics The treatment of pathological
conditions through the use of drugs; also called therapeutics.
(p. 17)
Prodrug An inactive drug dosage form that is converted to an
active metabolite by various biochemical reactions once it is
inside the body. (p. 24)
Receptor A molecular structure within or on the outer
surface of a cell. Receptors bind specific substances (e.g.,
drug molecules), and one or more corresponding cellular
effects (drug actions) occur as a result of this drug–receptor
interaction. (p. 28)
Steady state The physiological state in which the amount of
drug removed via elimination is equal to the amount of
drug absorbed with each dose. (p. 27)
Substrates Substances (e.g., drugs or natural biochemicals in
the body) on which enzymes act. (p. 25)
Synergistic effects Drug interactions in which the effect of a
combination of two or more drugs with similar actions is
16
PART 1 Pharmacology Basics
greater than the sum of the individual effects of the same
drugs given alone (compare with additive effects). (p. 31)
Therapeutic drug monitoring The process of measuring
drug levels to identify a patient’s drug exposure and to
allow adjustment of dosages with the goals of maximizing
therapeutic effects and minimizing toxicity. (p. 28)
Therapeutic effect The desired or intended effect of a
particular medication. (p. 28)
Therapeutic index The ratio between the toxic and
therapeutic concentrations of a drug. (p. 30)
Thin-film drug delivery Drug products that dissolve in the
mouth and are absorbed through the oral mucosa. (p. 18)
Time-release technology A technique used in tablets and
capsules such that drug molecules are released in the
patient’s gastrointestinal tract over an extended period.
(p. 18)
OVERVIEW
Any chemical that affects the physiological processes of a living
organism can broadly be defined as a drug. The study or science
of drugs is known as pharmacology. Pharmacology encompasses a variety of topics, including the following:
• Absorption
• Biochemical effects
• Biotransformation (metabolism)
• Distribution
• Drug history
• Drug origin
• Drug receptor mechanisms
• Excretion
• Mechanisms of action
• Physical and chemical properties
• Physical effects
• Therapeutic (beneficial) effects
• Toxic (harmful) effects
Pharmacology includes the following several subspecialty
areas: pharmaceutics, pharmacokinetics, pharmacodynamics,
pharmacogenetics (pharmacogenomics), pharmacoeconomics, pharmacotherapeutics, pharmacognosy, and toxicology.
Knowledge of these areas of pharmacology enables the nurse
to better understand how drugs affect humans. Without understanding basic pharmacological principles, the nurse cannot
fully appreciate the therapeutic benefits and potential toxicity
of drugs.
Throughout the process of its development, a drug will
acquire at least three different names. The chemical name
describes the drug’s chemical composition and molecular structure. The generic name, or nonproprietary name, is often much
shorter and simpler than the chemical name. The generic name
is used in most official drug compendiums to list drugs. The
trade name, or proprietary name, is the drug’s registered trademark and indicates that its commercial use is restricted to the
owner of the patent for the drug (Fig. 2.1). The patent owner is
Tolerance Reduced response to a drug after prolonged use.
(p. 30)
Toxic The quality of being poisonous (i.e., injurious to health
or dangerous to life). (p. 17)
Toxicity The condition of producing adverse bodily effects
due to poisonous qualities. (p. 28)
Toxicology The study of poisons, including toxic drug effects,
and applicable treatments. (p. 17)
Trade name The commercial name given to a drug product by
its manufacturer; also called the proprietary name. (p. 16)
Trough level The lowest concentration of a drug reached in
the body after it falls from its peak level, usually measured
in a blood sample for therapeutic drug monitoring.
(p. 28)
usually the manufacturer of the drug. Trade names are generally
created by the manufacturer with marketability in mind. For
this reason, they are usually shorter and easier to pronounce and
remember than generic names. The patent life of a newly discovered drug molecule in Canada is 20 years. This is the length of
time from patent approval until patent expiration. Because the
research processes for new drug development normally require
about 10 years, a drug manufacturer generally has the remaining
10 years for sales profits before patent expiration. A significant
amount of these profits serves to offset the multi-million–dollar
costs for research and development of the drug.
After the patent for a given drug expires, other manufacturers may legally begin to manufacture generic drugs with the
same active ingredient. At this point, the drug price usually
decreases substantially. Due to the high cost of drugs, many
institutions have implemented programs in which one drug in
a class of several drugs is chosen as the preferred agent, even
though the drugs do not have the same active ingredients. This
is called therapeutic equivalence. Before one drug can be therapeutically substituted for another, the drugs must have been
proven to have the same therapeutic effect on the body.
Drugs are grouped together based on their similar properties. This is known as a drug classification. Drugs can be classified by their structure (e.g., β-adrenergic blockers) or by their
therapeutic use (e.g., antibiotics, antihypertensives, antidepressants). Within the broad classification, each class may have subclasses—for example, penicillins are a subclass within the group
of antibiotics, and β-adrenergic blockers are a subclass within
the group of antihypertensives.
Three basic phases of pharmacology—pharmaceutics, pharmacokinetics, and pharmacodynamics—describe the relationship between the dose of a drug given to a patient and the activity
of that drug in treating the patient’s disorder. Pharmaceutics
is the study of how various dosage forms influence the way in
which the drug affects the body. Pharmacodynamics, on the
other hand, is the study of what the drug does to the body.
CHAPTER 2 Pharmacological Principles
Chemical name
(+/−)-2-(p-isobutylphenyl) propionic acid
Generic name
ibuprofen
Trade name
Advil, Motrin, others
17
CH3
CH3
CH
CH
CH2
COOH
CH3
Fig. 2.1 Chemical structure of the common analgesic ibuprofen and the chemical, generic, and trade
names for the drug.
Pharmacokinetics is the study of what the body does to
the drug, involving the processes of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics
involves drug–receptor relationships. Figure 2.2 illustrates the
three phases of drug activity, starting with the pharmaceutical
phase, proceeding to the pharmacokinetic phase, and finishing
with the pharmacodynamic phase.
Pharmacotherapeutics (also called therapeutics) focuses
on the clinical use of drugs to prevent and treat diseases.
It defines the principles of drug actions—the cellular processes that change in response to the presence of drug molecules. Some drug mechanisms of action are more clearly
understood than others. Drugs are categorized into pharmacological classes according to their physiological functions
(e.g., β-adrenergic blockers) and primary disease states
treated (e.g., anticonvulsants, anti-infectives). Under the
mandate of the Food and Drugs Act and Regulations, including the Controlled Drugs and Substances Act (Government
of
Canada,
2019
https://laws-lois.justice.gc.ca/eng/
acts/C-38.8/), Health Canada regulates the approval and
clinical use of all drugs, including the requirement of an
expiration date on all drugs. This textbook focuses almost
exclusively on current Health Canada–approved indications
for the drugs discussed in each chapter and on drugs that
are currently available in Canada at the time of this writing.
Only Health Canada–approved indications are permitted
to be described in the manufacturer’s written information,
or labelling, for a given drug product. At times, prescribers
may elect to use drugs for non–Health Canada–approved
indications. This use is known as off-label prescribing and
often requires seasoned clinical judgement on the part of
the prescriber. Evolving over time in clinical practice, previously off-label indications often become Health Canada–
approved indications for a given drug.
The study of the adverse effects of drugs and other chemicals
on living systems is known as toxicology. Toxic effects are often
an extension of a drug’s therapeutic action. Therefore, toxicology often involves overlapping principles of both pharmacotherapy and toxicology.
The study of natural (versus synthetic) drug sources
(both plants and animals) is called pharmacognosy.
Pharmacoeconomics focuses on the economic aspects of drug
therapy.
In summary, pharmacology is a dynamic science that
incorporates several different disciplines. Traditionally,
Dose of
formulated
drug
Administration
I
Pharmaceutical
phase
Disintegration
of dosage form
Dissolution of
drug
Drug available
for absorption
II
Pharmacokinetic
phase
Absorption,
distribution,
metabolism,
excretion
Drug available
for action
III
Pharmacodynamic
phase
Drug–receptor
interaction
Effect
Fig. 2.2 Phases of drug activity. (From McKenry, L. M., Tessier, E.,
& Hogan, M. (2006). Mosby’s pharmacology in nursing (22nd ed.). St.
Louis: Mosby.)
chemistry has been seen as the primary basis of pharmacology, but pharmacology also relies heavily on physiology and
biology.
PHARMACEUTICS
Different drug dosage forms have different pharmaceutical
properties. Dosage form determines the rate at which drug dissolution (dissolving of solid dosage forms and their absorption
[e.g., from gastrointestinal tract fluids]) occurs. A drug to be
ingested orally may be in either a solid form (tablet, capsule,
or powder) or a liquid form (solution or suspension). Table
2.1 lists various oral drug preparations and the relative rate
at which they are absorbed. Oral drugs that are liquids (e.g.,
18
PART 1 Pharmacology Basics
TABLE 2.1
Preparations
Drug Absorption of Various Oral
Liquids (e.g., elixirs, syrups)
Suspension solutions
Powders
Capsules
Tablets
Coated tablets
Enteric-coated tablets
Fastest
TABLE 2.2
Route
Forms
Enteral
Tablets, capsules, oral soluble wafers, pills, time-release
capsules, time-release tablets, enteric-coated tablets,
elixirs, suspensions, solutions, lozenges or troches, caplets,
rectal* suppositories, sublingual or buccal tablets
Parenteral
Injectable forms, solutions, suspensions, emulsions, powders
for reconstitution
Topical
Aerosols, ointments, creams, pastes, powders, solutions,
foams, gels, transdermal patches, inhalers, rectal* and
vaginal suppositories
Slowest
elixirs, syrups) are already dissolved and are usually absorbed
more quickly than solid dosage forms. Enteric-coated tablets, by
contrast, have a coating that prevents them from being broken
down in the acidic pH environment of the stomach and therefore are not absorbed until they reach the more alkaline pH of
the intestines. This pharmaceutical property results in slower
dissolution and slower absorption.
Particle size within a tablet or capsule can make different dosage forms of the same drug dissolve at different rates, become
absorbed at different rates, and thus have different times to
onset of action. An example is the difference between micronized fenofibrate and nonmicronized fenofibrate. Micronized
fenofibrate, for example, reaches a maximum concentration
peak faster than does the nonmicronized formulation. Dosage
form design for injectable drugs tends to be more straightforward than that for oral dosage forms. However, some injections
are carefully formulated to reduce drug toxicity (e.g., liposomal
amphotericin B).
Combination dosage forms contain multiple drugs in one
dose. Examples of these combination forms include the cholesterol and antihypertensive medications atorvastatin calcium/amlodipine besylate tablets called Caduet and bacitracin
zinc/neomycin sulphate/polymyxin B sulphate/hydrocortisone ointment (generic). There are numerous combination
dosage forms; key examples are cited in the various chapters
of this book.
A variety of dosage forms exist to provide both accurate
and convenient drug delivery systems (Table 2.2). These
delivery systems are designed to achieve a desired therapeutic response with minimal adverse effects. Many dosage
forms have been developed to encourage patient adherence
with the medication regime. Time-release technology is a
technique used in tablets and capsules such that drug molecules are released in the patient’s gastrointestinal tract over
an extended period of time. Use of this technology allows
drugs to be released continuously and more slowly into the
bloodstream. This results in prolonged drug absorption as
well as duration of action. This is the opposite of immediate-release dosage forms, which release all of the active
ingredients immediately upon dissolution in the gastrointestinal tract. Extended-release dosage forms are normally easily identified by various capital letter abbreviations attached
to their names. Examples of this nomenclature are SR (slow
release or sustained release), SA (sustained action), CR
Dosage Forms
*Note: Rectal enteral form is inserted into the rectum, while the topical rectal form is applied to the skin around the rectum.
(controlled release), XL (extended length), and XT (extended
time). Continuous release is another example. Convenience
of administration correlates strongly with patient adherence, because these forms often require fewer daily doses.
Extended-release oral dosage forms must not be crushed, as
this could cause accelerated release of drug from the dosage form and possible toxicity. Enteric-coated tablets also are
not recommended for crushing. This would cause disruption
of the tablet coating designed to protect the stomach lining
from the local effects of the drug and prevent the drug from
being prematurely disrupted by stomach acid. The ability to
crush a tablet or open a capsule can facilitate drug administration when patients are unable or unwilling to swallow
a tablet or capsule and when medications need to be given
through an enteral feeding tube. Capsules, powder, or liquid
contents can often be added to soft foods such as applesauce
or pudding or dissolved in a beverage. Granules contained in
capsules are usually for extended drug release and normally
should not be crushed or chewed by the patient. However,
they can often be swallowed when sprinkled on a soft food.
Consultation with a pharmacist, reading the product literature, or use of another suitable source is necessary if there is
any question about whether a drug can be crushed or mixed
with specific food or beverages.
An increasingly popular dosage form, thin-film drug
delivery, refers to drug products that dissolve in the mouth
and are absorbed through the oral mucosa. These include
orally disintegrating tablets as well as thin wafers that also
dissolve in the mouth when contact with liquid occurs.
Depending on the specific drug product, the dosage form
may dissolve on the tongue, under the tongue, or in the buccal (cheek) pocket.
The specific characteristics of various dosage forms have a
large impact on how and to what extent the drug is absorbed.
For a drug to work at a specific site in the body it must either
be applied directly at that site in an active form or have a way of
getting to that site. Oral dosage forms rely on gastric and intestinal enzymes and pH environments to break down the medication into particles that are small enough to be absorbed into the
circulation. Once absorbed through the mucosa of the stomach
CHAPTER 2 Pharmacological Principles
19
40 mg orally
administered drug
Heart
Stomach
2 mg of same
drug administered
intravenously
Systemic
circulation
(entire body)
Portal
circulation
(liver)
Target organ
(e.g., kidney)
Liver
Fig. 2.3 First-pass effect of a drug by the liver before its systemic availability. (From McKenry, L. M., &
Salerno, E. (1995). Mosby’s pharmacology in nursing (19th ed.). St. Louis: Mosby.)
or intestines, the drug is then transported to the site of action
by blood or lymph.
Many topically applied dosage forms work directly on the
surface of the skin. Once the drug is applied, it is already in a
form that allows it to act immediately. However, with other topical dosage forms, the skin acts as a barrier through which the
drug must pass to get to the circulation; once there, the drug
is then carried to the site of action (e.g., fentanyl transdermal
patches for pain).
Dosage forms that are administered via injection are called
parenteral forms. They must have certain characteristics to
be safe and effective. The arteries and veins that carry drugs
throughout the body can easily be damaged if the drug is too
concentrated or corrosive. To be administered safely, the pH
of injections must be similar to that of the blood. Parenteral
dosage forms that are injected intravenously are immediately
placed into solution in the bloodstream and do not have to be
dissolved in the body. Therefore, 100% absorption is assumed
to occur immediately upon intravenous or intra-arterial
injection.
PHARMACOKINETICS
A drug’s time to onset of action, time to peak effect, and duration
of action are all characteristics defined by pharmacokinetics.
Pharmacokinetics is the study of what happens to a drug from
the time it is put into the body until the parent drug and all
metabolites have left the body. Thus, the study of drug absorption, distribution, metabolism, and excretion represents the
combined focus of pharmacokinetics.
Absorption
Absorption is the movement of a drug from its site of administration into the bloodstream for distribution to the tissues.
Bioavailability describes the extent of drug absorption. For
example, a drug that is absorbed from the intestine must first
pass through the liver before it reaches the systemic circulation
(Fig. 2.3). If a large proportion of a drug is chemically changed
into inactive metabolites in the liver, then a much smaller
amount of drug will pass into the circulation (i.e., will be bioavailable). Such a drug is said to have a high first-pass effect
(e.g., oral nitrates). First-pass effect reduces the bioavailability
of drugs to less than 100%. Drugs administered by the intravenous route are 100% bioavailable because 100% of the drug
reaches the systemic circulation. Drugs administered by mouth
have reduced bioavailability (less than 100%) because a fraction
of the drug reaches the systemic circulation. If two medications
have the same bioavailability and same concentration of active
ingredient, they are said to be bioequivalent (e.g., a trade-name
drug and the same generic drug).
20
PART 1 Pharmacology Basics
Various factors affect the rate of drug absorption. How a
drug is administered, or its route of administration, affects the
rate and extent of absorption of that drug. Although a number
of dosage formulations are available for delivering medications,
they can all be categorized into three basic routes of administration: enteral (gastrointestinal tract), parenteral, and topical.
CASE STUDY
Nitroglycerin Therapy
Four patients with angina are receiving a form of
nitroglycerin, as follows:
Charlotte, age 88, takes 10 mg four times a day to
prevent angina.
Dale, age 63, takes a form that delivers 0.2 mg/hr,
also to prevent angina.
Raissa, age 58, takes 0.4 mg only if needed for
chest pain.
Kenneth, age 62, is in the hospital with severe,
unstable angina and is receiving 100 mcg/hr.
You may refer to the section on nitroglycerin in Chapter 24 or to a nursing drug
handbook to answer these questions.
1. State the route or form of nitroglycerin that each patient is receiving. In
addition, specify the generic name(s) and trade name(s) for each form.
2. For each patient, state the rationale for the route or form of drug that was
chosen. Which forms have immediate action? Why would this be important?
3. Which form or forms are most affected by the first-pass effect? Explain your
answer.
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
Route
Enteral Route. In enteral drug administration, the drug is
absorbed into the systemic circulation through the mucosa of
the stomach or small or large intestine. The rate of absorption
can be altered by many factors. Orally administered drugs are
absorbed from the intestinal lumen into the mesenteric blood
system and transported by the portal vein to the liver. Once the
drug is in the liver, hepatic enzyme systems metabolize it, and
the remaining active ingredients are passed into the general
circulation. Enteric coating is designed to protect the stomach by
having drug dissolution and absorption occur in the intestines.
Taking an enteric-coated medication with a large amount of
food may cause it to be dissolved by acidic stomach contents and
thus reduce intestinal drug absorption and negate the coating’s
stomach-protective properties. If a large proportion of a drug is
chemically processed into inactive metabolites in the liver, then
a much less active drug will make it into circulation. Such a drug
would have a high first-pass effect. Consequently, the oral dose
has to be calculated to compensate for the lower bioavailability.
For example, nitroglycerin administered orally undergoes rapid
liver metabolism and as a result, has almost no pharmacological
effect. If administered sublingually, the drug is absorbed into
the system circulation via the rich supply of blood vessels under
the tongue and is carried to its site of action prior to circulating
through the liver.
The same drug given intravenously will bypass the liver altogether. This prevents the first-pass effect from taking place and
therefore allows all of the drug to reach the circulation. For this
reason, parenteral doses of drugs with a high first-pass effect
are much smaller than enterally (orally) administered doses,
yet they produce the same pharmacological response. See Table
2.3 for further discussion of the advantages, disadvantages,
and nursing considerations as a result of the different routes of
administration.
Many factors can alter the absorption of drugs, including acid changes within the stomach, absorption changes in
the intestines, and the presence or absence of food and fluid.
Various factors that affect the acidity of the stomach include the
time of day; the age of the patient; and the presence and types
of medications (e.g., H2 blockers or proton pump inhibitors [see
Chapter 39]), foods, or beverages.
Anticholinergic drugs slow gastrointestinal transit time (or
the time it takes for substances in the stomach to be dissolved
for eventual transport to and absorption from the intestines).
This may reduce the amount of drug absorption and therapeutic
effect for acid-susceptible drugs that become broken down by
stomach acids. The presence of food may enhance the absorption of some fat-soluble drugs or of drugs that are more easily
broken down in an acidic environment.
Drug absorption may also be altered in patients who have
had portions of the small intestine removed because of disease.
This condition is known as short bowel syndrome. Similarly, bariatric weight loss surgery reduces the size of the stomach. As a
result, medication absorption can be altered because stomach
contents are delivered to the intestines more rapidly than usual
after such surgery. This phenomenon is called gastric dumping.
Examples of drugs to be taken on an empty stomach and those
to be taken with food are provided in Box 2.1. The stomach and
small intestine are highly vascularized. When blood flow to
the area is decreased, absorption may also be decreased. Sepsis
and exercise are examples of circumstances under which blood
flow to the gastrointestinal tract is often reduced. In both cases,
blood tends to be routed to the heart and other vital organs. In
exercise, blood is also routed to the skeletal muscles.
Sublingual and Buccal Routes. Drugs administered by the
sublingual route are absorbed rapidly into the highly vascularized
tissue under the tongue—the oral mucosa. Sublingual nitroglycerin
is an example. Sublingually administered drugs are absorbed
rapidly because the area under the tongue has a large blood supply.
These drugs bypass the liver and yet are systemically bioavailable.
The same applies for drugs administered by the buccal route (the
oral mucosa between the cheek and the gum). Through these
routes, drugs such as nitroglycerin are absorbed rapidly into the
bloodstream and delivered rapidly to their site of action (e.g.,
coronary arteries).
Parenteral Route. The parenteral route is the fastest route by
which a drug can be absorbed, followed by the enteral and the
topical routes. Parenteral is a general term meaning any route
of administration other than the gastrointestinal tract. It most
commonly refers to injection. Intravenous injection delivers the
drug directly into the circulation, where it is distributed with
the blood throughout the body. Drugs given by intramuscular
Routes of Administration and Related Nursing Considerations
Route
Advantages
Disadvantages
Nursing Considerations
Intravenous (IV)
Provides rapid onset (drug delivered
immediately to bloodstream); allows more
direct control of drug level in blood; gives
option of larger fluid volume, therefore
diluting irritating drugs; avoids first-pass
metabolism.
Higher cost; inconvenience (e.g., not self-administered);
irreversibility of drug action in most cases and inability
to retrieve medication; risk of fluid overload; greater
likelihood of infection; possibility of embolism.
Continuous intravenous infusions require frequent monitoring to be sure
that the correct
volume and amount are administered and that the drug reaches safe,
therapeutic blood levels. Intravenous drugs and solutions must be checked
for compatibilities. Intravenous sites are to be monitored for redness,
swelling, heat, and drainage—all indicative of
complications, such as thrombophlebitis. If intermittent intravenous
infusions are used, clearing or flushing of the line with normal saline
before and after is generally indicated
to keep the intravenous site patent and minimize incompatibilities.
Intramuscular (IM)
Intramuscular injections are good for poorly
soluble drugs, which are often given in “depot”
preparation form and are then absorbed over a
prolonged period; onsets of action differ
depending on route. IM route also provides a
more immediate onset of action than PO for
certain drugs prior to establishment of IV
access (e.g., in the emergency department)
or if the patient does not require IV access
but is vomiting.
Discomfort of injection; inconvenience; bruising;
slower onset of action compared to intravenous,
although quicker than oral in most situations.
Using landmarks to identify correct intramuscular site is always required and
recommended
as a nursing standard of care. For adults, the intramuscular site of choice
is the ventral gluteal muscle with use of a 38-mm (sometimes 25-mm
in extremely thin or emaciated patients) and 20- to 25-gauge needle for
aqueous solutions and 18- to 25-gauge needle
for viscous or oil-based solutions. However, the deltoid muscle in the upper
arm is the
site of choice for vaccine administration in adults. Selection of the correct
size of
syringe and needle is key to safe administration by these routes and is
based on
thorough assessment of the patient as well as the characteristics of the
drug.
Subcutaneous
Drugs given via the subcutaneous route are
those that require slow, sustained absorption
of a medication, such as insulin and
low-molecular-weight heparin solutions. It is
also often used in surgery and palliative care
for slower absorption of pain medication and
prolonged pain relief. The medication is
injected under the epidermis into the fat and
connective tissue beneath the dermis, where
there is less blood flow and consequently a
slower, steadier absorption rate compared
with that of the intramuscular route.
Discomfort of injection; inconvenience; bruising; slower
onset of action compared to intravenous/intramuscular,
although quicker than oral in most situations. A wide
variety of insulin pens and preloaded heparin syringes
with tiny needles are available, enabling the 90-degree
angle for injection. Subcutaneous injection into the
abdomen should be to the right or left of and 5 cm away
from the umbilicus to avoid the umbilical veins and the
risk of bleeding.
Using landmarks to identify the correct subcutaneous site is always required
and
recommended as a nursing standard of care. Common sites for injection
include the
lateral and posterior aspects of the upper arm and under the greater
trochanter of the
femur in the thigh and abdominal area. Subcutaneous injections are recommended to be given at a 90-degree angle with a proper-size syringe and
needle (4 to 8 mm); in
emaciated or extremely thin patients, the subcutaneous angle is 45 degrees.
Subcutaneous injections require a 26- to 30-gauge, 8-mm needle. Selection
of
correct size of syringe and needle is key to safe administration by the
subcutaneous
route and is based on thorough assessment of the patient as well as the
characteristics
of the drug.
CHAPTER 2 Pharmacological Principles
TABLE 2.3
21
Route
Advantages
Disadvantages
Nursing Considerations
Oral
Usually easier, more convenient, and less
expensive; safer than injection as dosing
more likely to be reversible in cases of
accidental ingestion (e.g., through induction
of emesis, administration of activated
charcoal).
Variable absorption; inactivation of some drugs by
stomach acid or pH; problems with first-pass effect or
presystemic metabolism; greater dependence of drug
action on patient variables.
Enteral routes include oral administration and involve a variety of dosage
forms (e.g., liquids, solutions, tablets, and enteric-coated pills or tablets).
Some medications are recommended to be taken with food, while others
are recommended not to be taken with food; it is also suggested that oral
dosage forms of drugs be taken with a sufficient amount of fluid, such as
180 to 240 mL of water. Other factors to consider include other medicines
being taken at the same time and concurrent use of dairy products or
antacids. If oral forms are given via nasogastric tube or gastrostomy tube,
tube placement in stomach must be assessed prior to giving the medication
and the patient’s head is to remain elevated; flushing the nasogastric tube
with at least 30 to 60 mL of water before and after giving the drug is recommended to help maintain tube patency and prevent clogging; enteric-coated
drugs cannot be crushed and administered via nasogastric tube, while capsules may be opened but granules are not to be crushed for administration.
Sublingual, buccal
Absorbed more rapidly from oral mucosa than
(subtypes of oral, but oral route and leads to more rapid onset of
more parenteral than action; avoids breakdown of drug by stomach
enteral)
acid; avoids first-pass metabolism because
gastric absorption is bypassed.
Patient may swallow pill instead of keeping under
tongue until dissolved; pills often smaller, increasing
difficulty to handle. Salivary secretions are necessary
for the absorption of sublingual medications.
Drugs given via the sublingual route are to be placed under the tongue;
once dissolved, the drug may be swallowed. When using the buccal route,
medication is placed between the cheek and gum. Both of these dosage
forms are relatively nonirritating; the drug usually is without flavour and is
water-soluble.
Rectal
Provides relatively rapid absorption; good
alternative when oral route not feasible;
useful for local or systemic drug delivery;
usually leads to mixed first-pass and
non–first-pass metabolism.
Possible discomfort and embarrassment
to patient; often higher cost than oral
route.
Absorption via this route is erratic and unpredictable, but it provides a safe
alternative when nausea or vomiting prevents oral dosing of drugs. The
patient must be placed on his left side so that the normal anatomy of
the colon allows safe and effective insertion of the rectal dosage form.
Suppositories are inserted using a gloved hand or gloved index finger and
water-soluble lubricant. Drug must be administered exactly as ordered.
Topical
Delivers medication directly to affected
area; decreases likelihood of systemic drug
effects.
Sometimes awkward to self-administer
(e.g., eye drops); can be messy;
usually higher cost than oral route.
Most dermatological drugs are given via topical route in form of a solution,
ointment, spray, or drops. Maximal absorption of topical drugs is enhanced
with skin that is clean and free of debris; if measurement of ointment is
necessary—such as with topical nitroglycerin—application must be done
carefully and per instructions (e.g., apply 2.5 cm of ointment). Gloves help
minimize cross-contamination and prevent absorption of drug into the
nurse’s own skin. If the patient’s skin is not intact, sterile technique is
needed.
Transdermal (subtype Provides relatively constant rate of drug
of topical)
absorption; one patch can last 1 to 7 days,
depending on drug; avoids first-pass
metabolism.
Rate of absorption can be affected by excessive
perspiration and body temperature; patch may peel
off; cost is higher; used patches must be disposed
of safely; may cause skin irritation.
Transdermal drugs should be placed on alternating sites and on a clean,
nonhairy, nonirritated area, and only after the previously applied patch has
been removed and that area cleansed and dried. Transdermal drugs generally come in a single-dose, adhesive-backed drug application system.
Inhalational
Rate of absorption can be too rapid, increasing the risk
of exaggerated drug effects; requires more patient
education for self-administration; some patients may
have difficulty with administration technique.
Inhaled medications are to be used exactly as prescribed and with clean
equipment. Instructions need to be given to the patient/family/caregiver
regarding medications to be used, as well as the proper use, storage, and
safekeeping of inhalers, spacers, and nebulizers. Chapter 10 describes and
shows how medications are inhaled.
Provides rapid absorption; drug delivered
directly to lung tissues, where most of these
drugs exert their actions.
PART 1 Pharmacology Basics
Routes of Administration and Related Nursing Considerations—cont’d
22
TABLE 2.3
CHAPTER 2 Pharmacological Principles
Drugs to Be Taken on an Empty
Stomach and With Food
BOX 2.1
Many medications are taken on an empty stomach with an adequate intake of
fluid (180 to 240 mL of water). The nurse must give patients specific instructions regarding those medications not to be taken with food but on an empty
stomach. Examples include alendronate sodium and risedronate sodium.
Medications that are generally taken with food include carbamazepine, iron
and iron-containing products, hydralazine, lithium, propranolol, spironolactone, nonsteroidal anti-inflammatory drugs, and theophylline.
Often, macrolides and oral opioids are taken with food (even though they
are specified to be taken with a full glass of water and on an empty stomach)
to minimize the gastrointestinal irritation associated with these drugs. If you
are in doubt, consult with a licensed pharmacist or a current authoritative
drug resource.
injection and subcutaneous injection are absorbed more slowly
than those given intravenously. These drug formulations are
usually absorbed over a period of several hours; however, some are
specially formulated to be released over days, weeks, or months.
Drugs can be injected intradermally, subcutaneously, intravenously, intramuscularly, intrathecally, intra-articularly, or
intra-arterially. Physicians and advanced practice nurses usually
give intra-arterial, intrathecal, or intra-articular injections.
Medications given by the parenteral route have the advantage of
bypassing the first-pass effect of the liver. Parenteral administration offers an alternative route of delivery for those medications
that cannot be given orally and poses fewer obstacles to absorption. However, drugs that are administered by the parenteral
route must still be absorbed into cells and tissues before they
can exert their pharmacological effect (see Table 2.3).
PREVENTING MEDICATION ERRORS
Does IV = PO?
The prescriber writes an order for “furosemide 80 mg IV STAT × 1 dose” for a
patient who is short of breath because of pulmonary edema. When the nurse
goes to give the drug, only the PO form is immediately available. Someone
must go to the pharmacy to pick up the IV dose. Another nurse says, “Go ahead
and give the pill. He needs it fast. It’s all the same!” But is it?
Remember, the oral forms of medications must be processed through the
gastrointestinal tract, be absorbed through the small intestine, and undergo
the first-pass effect in the liver before the drug can reach the intended site of
action. In contrast, IV forms are injected directly into the circulation and can
act almost immediately because the first-pass effect is bypassed. The time
until onset of action for the PO form is 30 to 60 minutes; for the IV form, this
time is 5 minutes. This patient is in respiratory distress, and the immediate
effect of the diuretic is desired. In addition, because of the first-pass effect,
the available amount of orally administered drug that reaches the site of
action would be less than the available amount of intravenously administered
drug. Therefore, IV does NOT equal PO! Never change the route of administration of a medication; if questions come up, always check with the prescriber.
Subcutaneous, Intradermal, and Intramuscular Routes.
Injections into the fatty subcutaneous tissues under the dermal
layer of the skin are referred to as subcutaneous injections.
Injections under the more superficial skin layers immediately
23
underneath the epidermal layer of skin and into the dermal
layer are known as intradermal injections. Injections given into
the muscle beneath the subcutaneous fatty tissue are referred to
as intramuscular injections. Muscles have a greater blood supply
than the skin does; therefore, drugs injected intramuscularly are
typically absorbed faster than drugs injected subcutaneously.
Absorption from either of these sites may be increased by
applying heat to the injection site or by massaging the site. Both
methods increase blood flow to the area, thereby enhancing
absorption. In contrast, the presence of cold, hypotension,
or poor peripheral blood flow compromises the circulation,
reducing drug activity by reducing drug delivery to the tissues.
Most intramuscularly injected drugs are absorbed over several
hours. However, specially formulated long-acting intramuscular
dosage forms called depot drugs have been designed for slow
absorption over a period of several days to a few months or
longer. The intramuscular corticosteroid methylprednisolone
acetate can provide anti-inflammatory effects for several weeks.
The intramuscular contraceptive medroxyprogesterone acetate
normally prevents pregnancy for 3 months per dose.
Topical Route. The topical route of drug administration
involves application of medications to various body surfaces.
Several topical drug delivery systems exist. Topically
administered drugs can be applied to the skin, eyes, ears, nose,
lungs, rectum, or vagina. Topical application delivers a uniform
amount of drug over a longer period, but the effects of the
drug are usually slower in their onset and more prolonged in
their duration of action as compared with oral or parenteral
administration. This can be a problem if the patient begins to
experience adverse effects from the drug and a considerable
amount of drug has already been absorbed. All topical routes of
drug administration avoid first-pass effects of the liver, except
for rectal drug administration. Because the rectum is part of
the gastrointestinal tract, some drug will be absorbed into the
capillaries that feed the portal vein to the liver. However, some
drugs will also be absorbed locally into the perirectal tissues.
Therefore, rectally administered drugs are said to have a mixed
first-pass and non–first-pass absorption and metabolism.
Box 2.2 lists the drug routes and indicates whether they are
associated with first-pass effects in the liver.
Ointments, gels, and creams are common types of topically
administered drugs. Examples include sunscreens, antibiotics, and nitroglycerin ointment. The drawback to their use is
that their systemic absorption is often erratic and unreliable.
Generally, these medications are commonly used for local
effects rather than for systemic effects. Topically applied drugs
can also be used in the treatment of illnesses of the eyes, ears,
and sinuses. Eye, ear, and nose drops are administered primarily
for local effects, whereas nasal sprays may be used for both systemic (e.g., sumatriptan for migraine headaches) and local (e.g.,
oxymetazoline for nasal sinus congestion). Vaginal medications
may also be given for systemic effects (e.g., progestational hormone therapy with progesterone vaginal suppositories) but are
more commonly used for local effects (e.g., treatment of vaginal
infection with miconazole vaginal cream).
Transdermal Route. Transdermal drug delivery through
adhesive drug patches is an elaborate topical route of drug
24
PART 1 Pharmacology Basics
BOX 2.2
Drug Routes and First-Pass Effects
First-Pass Routes
Hepatic arterial
Oral
Portal venous
Rectal*
Non–First-Pass Routes
Aural (instilled into the ear)
Buccal
Inhaled
Intra-arterial
Intramuscular
Intranasal
Intraocular
Intravaginal
Intravenous
Subcutaneous
Sublingual
Transdermal
*Leads to both first-pass and non–first-pass effects.
administration that is commonly used for systemic drug
effects. Some examples of drugs administered by this route are
fentanyl (for pain), nitroglycerin (for angina), nicotine (for
smoking cessation), estrogen (for menopausal symptoms), and
rivastigmine (for Alzheimer’s disease). Transdermal patches are
usually designed to deliver a constant amount of drug per unit
of time for a specified time period. For example, a nitroglycerin
patch may deliver 0.2, 0.4, or 0.6 mg/hr over 24 hours, whereas
a fentanyl patch may deliver 25 to 100 mcg/hr over a 72-hour
period.
This route is suitable for patients who cannot tolerate oral
administration and provides a convenient method for drug
delivery.
Inhalation Route. Inhalation is another type of topical
drug administration. Inhaled drugs are delivered to the lungs
as micrometre-sized drug particles. This small drug size is
necessary for the drug to be transported to the small, thin-walled
air sacs (alveoli) within the lungs. Once the small particles of
drug are in the alveoli, drug absorption is rapid via capillary
contact. Many pulmonary and other types of diseases can be
treated with such topically inhaled drugs. Examples of inhaled
drugs are zanamivir, used for the prevention of influenza;
salbutamol sulphate, used to treat bronchial constriction in
individuals with asthma; and fluticasone propionate, used for
its anti-inflammatory properties in patients with asthma and
allergies.
Distribution
Distribution refers to the transport of a drug by the bloodstream
to its site of action (Fig. 2.4). Drugs are distributed first to those
areas with extensive blood supply. Areas of rapid distribution
include the heart, liver, kidneys, and brain. Areas of slower
distribution include muscle, skin, and fat. Once a drug enters
the circulating blood, it is distributed throughout the body. At
this point, it is also starting to be eliminated by the organs that
metabolize and excrete drugs—primarily the liver and kidneys.
Only drug molecules that are not bound to plasma proteins can
freely distribute to extravascular tissue (outside the blood vessels) to reach their site of action. Albumin is the most common
blood protein and carries the majority of protein-bound drug
molecules (Fig. 2.5). If a given drug binds to albumin, only a
limited amount of the drug is not bound. This unbound portion is pharmacologically active and is considered “free” drug,
whereas “bound” drug is pharmacologically inactive. Certain
conditions that cause low albumin levels, such as extensive
burns and malnourished states, result in a larger fraction of free
(unbound and active) drug. This situation can raise the risk of
drug toxicity.
When an individual is taking two medications that are highly
protein bound, these medications may compete for binding
sites on the albumin protein. Because of this competition, there
is more free, unbound drug. This can lead to an unpredictable
drug response called a drug–drug interaction. A drug–drug
interaction occurs when the presence of one drug decreases or
increases the action of another drug administered concurrently
(i.e., given at the same time).
A theoretical volume, called the volume of distribution, is
sometimes used to describe the potential volume within various
areas where drugs may be distributed. These areas, or compartments, may be the blood (intravascular space), total body water,
body fat, or other body tissues and organs. Typically, a drug that
is highly water soluble (hydrophilic) will have a small volume of
distribution and high blood concentrations. In contrast, fat-soluble drugs (lipophilic) have a large volume of distribution and
low blood concentrations.
There are some sites in the body into which it may be difficult to distribute a drug. These sites typically either have a poor
blood supply (e.g., bone) or have physiological barriers that
make it difficult for drugs to pass through (e.g., the brain due to
the blood–brain barrier).
Metabolism
Metabolism, also referred to as biotransformation, is the next
step after absorption and distribution. It involves the biochemical alteration of a drug into any of the following: an inactive
metabolite, a more soluble compound, a more potent metabolite (as in the conversion of an inactive prodrug to its active
form), or a less active metabolite. The organ most responsible
for the biotransformation or metabolism of drugs is the liver.
Other metabolic tissues include the skeletal muscles, kidneys,
lungs, plasma, and intestinal mucosa.
Hepatic metabolism involves the activity of a large class
of enzymes, the cytochrome P450 enzymes (or simply P450
enzymes), also known as microsomal enzymes. These enzymes
control a variety of reactions that aid in the metabolism of medications. They are largely targeted against lipid-soluble (nonpolar [no charge]) drugs (also known as lipophilic [“fat loving”]),
which are typically difficult to eliminate. These include most
medications. Those medications with water-soluble (polar or
hydrophilic [“water loving”]) molecules may be more easily
metabolized by simpler chemical reactions such as hydrolysis. Some of the chemical reactions by which the liver can
25
CHAPTER 2 Pharmacological Principles
Parenteral
drug
Tissue receptors
or sites of action
Storage
sites
Major site for
metabolism
Plasma
Free
drug
Oral
drug
GI
tract
Proteinbound
drug
Metabolites
Liver
Excretion
(kidneys—
major site)
Fig. 2.4 Drug transport in the body.
Capillary cell wall
Plasma
Albumin
Albumin
Bound drug
Unbound
free drug
Albumin
Capillary cell pore
Fig. 2.5 Protein binding of drugs. Albumin is the most prevalent
protein in plasma and the most important of the proteins to which
drugs bind. Only unbound (free) drug molecules can leave the
vascular system. Bound molecules are too large to fit through the
pores in the capillary wall.
metabolize drugs are listed in Table 2.4. Drug molecules that
are the metabolic targets of specific enzymes are said to be substrates for those enzymes. Specific P450 enzymes are identified
by standardized number and letter designations. Some of the
most common P450 enzymes and their corresponding common
drug substrates are listed in Table 2.5.
The biotransformation capabilities of the liver can vary considerably from patient to patient. Age can alter biotransformation (young or older adult patient) as can an unhealthy liver. The
various factors that can alter biotransformation include genetics, diseases, and the concurrent use of other medications (Table
2.6). Nurses must be alert to the various factors that can alter
transformation with the accumulation of active metabolites and
the potential for subsequent toxicity.
Many drugs can inhibit drug-metabolizing enzymes; these
drugs are called enzyme inhibitors. Decreases or delays in drug
metabolism result in the accumulation of the drug and prolongation of the effects of the drug, which can lead to drug toxicity.
In contrast, some drugs can stimulate drug metabolism and are
called enzyme inducers. The presence of these drugs can cause
decreased pharmacological effects. This often occurs with the
repeated administration of certain drugs that stimulate the formation of new microsomal enzymes.
Excretion
Excretion is the elimination of drugs from the body. Whether
they are parent compounds or active or inactive metabolites, all
26
PART 1 Pharmacology Basics
TABLE 2.4
Mechanisms of Biotransformation
Type of Biotransformation
Oxidation
Reduction
Hydrolysis
Combination with another substance (e.g.,
glucuronide, glycine, sulphate, methyl groups,
alkyl groups)
}
Mechanism
Chemical reactions
Conjugation (e.g., glucuronidation, glycination,
sulfation methylation, alkylation)
Common Liver Cytochrome P450
Enzymes and Corresponding Drug Substrates
TABLE 2.5
Enzyme
Common Drug Substrates
1A2
amitriptyline, caffeine, theophylline, verapamil, warfarin
2C9
diclofenac, glyburide, ibuprofen, losartan, rosiglitazone,
tamoxifen
2C19
amitriptyline, diazepam, phenytoin, proton pump inhibitors,
propranolol
2D6
amitriptyline, carvedilol, codeine, fentanyl, fluoxetine,
haloperidol, hydrocodone, oxycodone, paroxetine, tricyclic
antidepressants, risperidone, timolol
2E1
acetaminophen, ethanol
3A4
azole antifungals, amiodarone, atorvastatin, many chemotherapeutic drugs, diltiazem, ethinyl estradiol, indinavir,
lidocaine, lovastatin, macrolides, progesterone, ritonavir,
simvastatin, testosterone, verapamil
Examples of Conditions and
Drugs That Affect Drug Metabolism
TABLE 2.6
DRUG METABOLISM
Category
Example
Diseases
Cardiovascular
dysfunction
X
Kidney insufficiency
X
Starvation
X
Condition
Increased
Obstructive jaundice
X
Genetic constitution
X*
Fast acetylator
X
Slow acetylator
Drugs
Barbiturates
Decreased
X*
X
X
erythromycin (P450
inhibitor)
X
ketoconazole (P450
inhibitor)
X
phenytoin (P450
inducer)
rifampin (P450
inducer)
X
X
*Whether a person is a poor or high metabolizer depends on the individual genetic makeup.
}
Result
Increase polarity of chemical, making it more water
soluble and more easily excretable. This often
results in a loss of pharmacological activity. Form
a less toxic product with less activity.
drugs must eventually be removed from the body. The primary
organ responsible for this elimination is the kidney. Two other
organs that play an important role in the excretion of drugs are
the liver and the bowel. Most drugs are metabolized in the liver
by various mechanisms. Therefore, by the time most drugs reach
the kidneys, they have undergone extensive biotransformation,
where the drug is converted to a less active form, and only a relatively small fraction of the original drug is excreted as the original compound. Other drugs may bypass hepatic metabolism
and reach the kidneys in their original form. Drugs that have
been metabolized by the liver become more polar and water-soluble. This change makes their elimination by the kidney much
easier because the urinary tract is water-based. The kidneys are
also capable of metabolizing various drugs, although usually to
a lesser extent than the liver.
The actual act of kidney excretion is accomplished through
glomerular filtration, active tubular reabsorption, and active
tubular secretion. Free (unbound) water-soluble drugs and
metabolites go through passive glomerular filtration. Many substances present in the nephrons go through active reabsorption
and are taken back up into the circulation and transported away
from the kidney. This process is an attempt by the body to retain
needed substances. Some substances may also be secreted into
the nephron from the vasculature surrounding it. The processes
of filtration, reabsorption, and secretion in urinary elimination
are shown in Fig. 2.6. Chronic kidney disease affects renal drug
elimination. Certain drugs may require dosage adjustments
(e.g., dose reductions or less frequent dosing) based on creatinine clearance or glomerular filtration rate.
The excretion of drugs by the intestines is another common
route of elimination. This process is referred to as biliary excretion. Drugs eliminated by this route are taken up by the liver,
released into the bile, and eliminated in the feces. Once certain drugs, such as fat-soluble drugs, are in the bile, they may
be reabsorbed into the bloodstream, returned to the liver, and
again secreted into the bile. This process is called enterohepatic
recirculation. Enterohepatically recirculated drugs persist in the
body for much longer periods. Less common routes of elimination are the lungs and the sweat, salivary, and mammary glands.
Half-Life
Another pharmacokinetic variable is the half-life of a drug. The
half-life is the time required for serum drug levels to be reduced
by one-half (50%) during the elimination phase. It is a measure
CHAPTER 2 Pharmacological Principles
27
Drug
Afferent
arteriole
Glomerulus
GFR ! 125
mL/min
Distal
tubule
Filtration
Efferent
arteriole
Proximal
tubule
Reabsorption
Collecting
duct
Secretion
Drug and metabolites
excreted in urine
Loop of Henle
Fig. 2.6 Renal drug excretion. The primary processes involved in drug excretion and the approximate
location where these processes take place in the kidney are illustrated. GFR, glomerular filtration rate.
TABLE 2.7
Example of a Drug Half-Life Viewed From Different Perspectives
Perspectives
Hours after peak concentration
Drug concentration (mg/L)
Changing Values
0
100 (peak)
8
16
24
50
25
12.5
32
6.25
40
3.125 (trough)
Number of half-lives
0
1
2
3
4
5
Percentage of drug removed
0
50
75
88
94
97
of the rate at which the drug is eliminated from the body. For
instance, if the peak level of a particular drug is 100 mg/L and
the measured drug level in 8 hours is 50 mg/L, then the estimated half-life for that drug is 8 hours. The concept of drug
half-life viewed from several different perspectives is shown in
Table 2.7.
After about five half-lives, most drugs are effectively removed
from the body. At that time approximately 97% of the drug has
been eliminated, and what little amount remains is too small to
have either therapeutic or toxic effects.
The concept of half-life is clinically useful for determining
when a steady state will be reached in a patient taking a drug.
Steady state refers to the physiological state in which the amount
of drug removed via elimination (e.g., kidney clearance) is equal
to the amount of drug absorbed with each dose. This physiological plateau phenomenon typically occurs after four to five
half-lives of administration of a drug. Therefore, if a drug has an
extremely long half-life, it will take much longer for the drug to
reach steady-state blood levels. Once steady-state blood levels
have been reached, there are consistent levels of drug in the
body that correlate with maximum therapeutic benefits.
Onset, Peak, and Duration
The pharmacokinetic terms absorption, distribution, metabolism, and excretion are all used to describe the movement of
drugs through the body. The term drug actions refers to the processes involved in the interaction between a drug and a cell (e.g.,
a drug’s action on a receptor). The terms onset, peak, duration,
and trough are used to describe drug effects. Peak and trough
are also used to describe drug concentrations, which are usually
measured from blood samples.
A drug’s onset of action is the time required for the drug to elicit
a therapeutic response. A drug’s peak effect is the time required for
it to reach its maximal therapeutic response. Physiologically, this
point corresponds to increasing drug concentrations at the site of
action. The duration of action of a drug is the length of time that
its concentration is sufficient (without more doses) to elicit a therapeutic response. These concepts are illustrated in Fig. 2.7.
28
PART 1 Pharmacology Basics
Toxic level
20
Peak level
18
Distribution
16
14
rpt
in
at
io
n
Ab
so
10
Therapeutic
range/index
im
ion
12
El
8
Minimal effective
concentration
6
4
2
0
1
2
3
4
5
6
7
8
9
10
11
12
Administration
of drug
Onset
of
action
Duration of action
Termination
of
action
Fig. 2.7 Characteristics of drug effects and relationship to the therapeutic window. MEC, minimal effective concentration.
The length of time until the onset, peak of action, and duration of action play an important part in determining the peak
level (highest blood level) and trough level (lowest blood level)
of a drug. If the peak blood level is too high, then drug toxicity
may occur. The toxicity may be mild, such as intensification of
the effects of the given drug (e.g., excessive sedation resulting
from overdose of a drug with sedative properties). However, it
can also be severe (e.g., damage to vital organs due to excessive
drug exposure). If the trough blood level is too low, then the
drug may not be at therapeutic levels to produce a response.
(A common example is antibiotic drug therapy with aminoglycoside antibiotics; see Chapter 44). In therapeutic drug monitoring, peak (highest) and trough (lowest) values are measured
to verify adequate drug exposure, maximize therapeutic effects,
and minimize drug toxicity. This monitoring is often carried
out by a clinical pharmacist working with other members of the
health care team.
PHARMACODYNAMICS
Pharmacodynamics is the relationship between drug concentrations and the pharmacological response (actions of the drug).
Drug-induced changes in normal physiological functions are
explained by the principles of pharmacodynamics. A positive
change in a faulty physiological system is called a therapeutic effect of a drug. Such an effect is the goal of drug therapy.
Understanding the pharmacodynamic characteristics of a drug
can aid in assessing the drug’s therapeutic effect.
Mechanism of Action
Drugs can produce actions (therapeutic effects) in several ways.
The effects of a particular drug depend on the cells or tissue
targeted by the drug. Once the drug is at the site of action, it
can modify (increase or decrease) the rate at which that cell or
tissue functions, or it can modify the strength of function of
that cell or tissue. A drug cannot, however, cause a cell or tissue
to perform a function that is not part of its natural physiology.
Drugs can exert their actions in three basic ways: through
receptors, enzymes, and nonselective interactions. It should also
be noted that not all mechanisms of action have been identified
for all drugs. Thus, a drug may be said to have an unknown
or unclear mechanism of action, even though it has observable
therapeutic effects in the body.
Receptor Interactions
A receptor can be defined as a reactive site on the surface or
inside of a cell. If the mechanism of action of a drug involves a
receptor interaction, then the molecular structure of the drug
is critical. Drug–receptor interaction is the joining of the drug
molecule with a reactive site on the surface of a cell or tissue.
Most commonly, this site is a protein structure within the cell
membrane. Once a drug binds to and interacts with the receptor,
a pharmacological response is produced (Fig. 2.8). The degree
to which a drug attaches and binds with a receptor is called its
affinity. The drug with the best “fit” and strongest affinity for the
receptor will elicit the greatest response from the cell or tissue.
A drug becomes bound to the receptor through the formation
of chemical bonds between the receptor on the cell and the
active site on the drug molecule. Drugs interact with receptors
in different ways, by either eliciting or blocking a physiological
response. Table 2.8 describes the different types of drug–receptor interaction.
Enzyme Interactions
Enzymes are substances that catalyze nearly every biochemical reaction in a cell. Drugs can produce effects by interacting
with these enzyme systems. For a drug to alter a physiological
response in this way, it may either inhibit (more common) or
CHAPTER 2 Pharmacological Principles
Natural
chemical
Natural
chemical
Agonist
drug
Antagonist
drug
Receptor
site
Receptor
site
Normal
response
Mimicked
response
Receptor
site
Blocked
response
Fig. 2.8 Drugs act by forming a chemical bond with specific receptor sites, similar to a key and lock—the better the “fit,” the better the
response. Drugs with complete attachment and response are called
agonists. Drugs that attach but do not elicit a response are called
antagonists. Drugs that attach, elicit some response, and also block
other responses are called partial agonists or agonist–antagonists.
TABLE 2.8
Drug–Receptor Interactions
Drug Type
Action
Agonist
Drug binds to the receptor; there is a response.
Partial agonist
(agonist–
antagonist)
Drug binds to the receptor; the response is diminished
compared with the response elicited by an agonist.
Antagonist
Drug binds to the receptor; there is no response. Drug
prevents binding of agonists.
Competitive
antagonist
Drug competes with the agonist for binding to the
receptor. If it binds, there is no response.
Noncompetitive
antagonist
Drug combines with different parts of the receptor and
inactivates it; agonist then has no effect.
enhance (less common) the action of a specific enzyme. This
process is called selective interaction. Drug–enzyme interaction
occurs when the drug chemically binds to an enzyme molecule
in such a way that it alters (inhibits or enhances) the enzyme’s
interaction with its normal target molecules in the body.
Nonselective Interactions
Drugs with nonspecific mechanisms of action do not interact
with receptors or enzymes. Instead, their main targets are cell
membranes and various cellular processes such as metabolic
activities. These drugs can either physically interfere with or
chemically alter cellular structures or processes. Some cancer
drugs and antibiotics have this mechanism of action. By incorporating themselves into the normal metabolic process, they
cause a defect in the final product or state. This defect may be
an improperly formed cell wall that results in cell death through
cell lysis, or it may be the lack of a necessary energy substrate,
which leads to cell starvation and death.
PHARMACOTHERAPEUTICS
Before drug therapy is initiated, an end point or expected outcome of therapy should be established. This desired therapeutic
29
outcome is patient specific, established in collaboration with
the patient, and if appropriate, determined with other members
of the health care team. Outcomes need to be clearly defined
and must be either measurable or observable by patient monitoring. Outcome goals must be realistic and prioritized so that
drug therapy begins with interventions that are essential to the
patient’s well-being. Examples include curing a disease, eliminating or reducing a pre-existing symptom, arresting or slowing
a disease process, preventing a disease or other unwanted condition, or otherwise improving quality of life.
Patient therapy assessment is the process by which a health care
provider integrates knowledge of medical and drug-related facts
with information about a specific patient’s medical and social history. Items to be considered in the assessment are drugs currently
used (prescription drugs, over-the-counter drugs, natural health
products, and illicit drugs), pregnancy and breastfeeding status,
and concurrent illnesses that could contraindicate initiation of
a given medication. A contraindication for a medication is any
patient condition, especially a disease state, that makes the use of
the medication dangerous for the patient. Careful attention to this
assessment process helps to ensure an optimal therapeutic plan.
The implementation of a treatment plan can involve several types
and combinations of therapies. The type of therapy can be categorized as acute, maintenance, supplemental (or replacement),
palliative, supportive, prophylactic, or empirical.
Types of Therapy
Acute Therapy
Acute therapy often involves more intensive drug therapy and is
implemented in patients who are acutely ill (those with a rapid
onset of illness) or even critically ill. It is often needed to sustain
life or treat disease. Examples are the administration of vasopressors to maintain blood pressure and cardiac output after
open heart surgery, the use of volume expanders for a patient
who is in shock, and intensive chemotherapy for a patient with
newly diagnosed cancer.
Maintenance Therapy
Maintenance therapy typically does not eradicate problems the
patient may already have but does prevent progression of a disease or condition. It is used for the treatment of chronic illnesses
such as hypertension. In the latter case, maintenance therapy
maintains the patient’s blood pressure within target limits, which
prevents certain end-organ damage. Another example of maintenance therapy is the use of oral contraceptives for birth control.
Supplemental Therapy
Supplemental (or replacement) therapy supplies the body with
a substance needed to maintain normal function. This substance may be needed because it cannot be made by the body or
because it is produced in insufficient quantity. Examples are the
administration of insulin to patients with diabetes and of iron to
patients with iron-deficiency anemia.
Palliative Therapy
The goal of palliative therapy is to make the patient as comfortable
as possible. Palliative therapy focuses on providing patients with
30
PART 1 Pharmacology Basics
relief from the symptoms, pain, and stress of a serious illness. The
goal is to improve quality of life for both the patient and the family.
It is typically used in the end stages of an illness, when all attempts
at curative therapy have failed; however, it can be provided along
with curative treatment. Examples are the use of high-dose opioid
analgesics to relieve pain in the final stages of cancer.
Supportive Therapy
Supportive therapy maintains the integrity of body functions
while the patient is recovering from illness or trauma. Examples
are provision of fluids and electrolytes to prevent dehydration in
a patient with influenza who is vomiting and has diarrhea, and
administration of fluids, volume expanders, or blood products
to a patient who has lost blood during surgery.
Prophylactic Therapy and Empirical Therapy
Prophylactic therapy is drug therapy provided to prevent illness or other undesirable outcome during planned events. An
example is the administration of disease-specific vaccines to
individuals travelling to geographic areas where a given disease
is known to be endemic.
Empirical therapy is based on clinical probabilities. It
involves administration of a drug when a certain pathological
condition has an uncertain but high likelihood of occurrence
based on the patient’s initial presenting symptoms. A common
example is use of antibiotics active against the organism most
commonly associated with a specific infection before the results
of the culture and sensitivity reports are available.
Monitoring
Once the appropriate therapy has been implemented, the effectiveness of that therapy—that is, the clinical response of the
patient to the therapy—must be evaluated. Evaluating the clinical response requires familiarity with both the drug’s intended
therapeutic action (beneficial effects) and its unintended possible adverse effects (predictable adverse drug reactions).
Examples of monitoring include observing for the therapeutic
effect of reduced blood pressure following administration of
antihypertensive drugs and observing for the toxic effect of
leukopenia after administering antineoplastic (cancer chemotherapy) drugs. Another example is performing a pain assessment after giving pain medication. It should be noted that this
text generally highlights only the most common adverse effects
of a given drug, but it may have many other, less commonly
reported adverse effects. Always keep in mind that patients
may sometimes experience less common and less readily identifiable adverse drug effects. Consult comprehensive references,
a pharmacist, or poison control centre staff whenever there
is uncertainty regarding adverse effects that a patient may be
experiencing.
All drugs are potentially toxic and can have cumulative
effects. Recognizing these toxic effects and knowing their manifestations are integral components of the monitoring process. A
drug can accumulate when it is absorbed more quickly than it is
eliminated or when it is administered before the previous dose
has been metabolized or cleared from the body. Knowledge of
the organs responsible for metabolizing and eliminating a drug,
combined with knowledge of how a particular drug is metabolized and excreted, enables the nurse to anticipate problems and
treat them appropriately if they occur.
Therapeutic Index
The ratio of a drug’s toxic level to the level that provides therapeutic benefits is referred to as the drug’s therapeutic index.
The safety of a drug therapy is determined by this index. A low
therapeutic index means that the difference between a therapeutically active dose and a toxic dose is small. This type of drug
has a greater likelihood than other drugs of causing an adverse
reaction, and therefore its use requires closer monitoring.
Examples of such drugs are warfarin and digoxin. In contrast, a
drug with a high therapeutic index, such as amoxicillin, is rarely
associated with overdose events.
Drug Concentration
All drugs reach a certain concentration in the blood. Drug concentrations can be an important tool for evaluating the clinical response
to drug therapy. Certain drug levels are associated with therapeutic responses, whereas other drug levels are associated with toxic
effects. Toxic drug levels are typically seen when the body’s normal
mechanisms for metabolizing and excreting drugs are compromised. This commonly occurs when liver and kidney functions are
reduced or when the liver or kidneys are immature (as in neonates).
Dosage adjustments should be made in these patients to appropriately accommodate their reduced metabolism and excretion.
Patient’s Condition
Another patient-specific factor to be considered is the patient’s
weight (e.g., obese or weakness or wasting of the body), presence of a critical illness, and the patient’s concurrent diseases
or other medical conditions. A patient’s response to a drug may
vary greatly depending on physiological and psychological
demands. Disease of any kind, infection, cardiovascular function, and gastrointestinal function are just a few of the physiological elements that can alter a patient’s therapeutic response.
Stress, depression, and anxiety can also be important psychological factors affecting response.
Tolerance and Dependence
To provide optimal drug therapy, it is important to understand
and differentiate between tolerance and dependence. Tolerance
is a decreasing response to repeated drug doses. Dependence is
a physiological or psychological need for a drug. Physical dependence is the physiological need for a drug to avoid physical withdrawal symptoms (e.g., tachycardia in a patient dependent on
opioids). Psychological dependence, also known as addiction,
is the obsessive desire for the effects of a drug. Addiction often
involves the recreational use of drugs such as benzodiazepines,
narcotics, and amphetamines but can also occur as a result of
chronic persistent pain. See Chapter 18 for further discussion of
dependence and addiction.
Interactions
Drugs may interact with other drugs, with foods, or with
agents administered as part of laboratory tests. Knowledge
CHAPTER 2 Pharmacological Principles
TABLE 2.9
Pharmacokinetic
Phase
31
Examples of Drug Interactions and Their Effects on Pharmacokinetics
Drug
Mechanism
Result
Absorption
Antacid with levofloxacin
hemihydrate
Antacids bind to the levofloxacin
hemihydrate, preventing adequate
absorption
Decreased effectiveness of levofloxacin hemihydrate,
resulting from decreased blood levels (harmful)
Distribution
warfarin with amiodarone
Both drugs compete for
protein-binding sites
Higher levels of free (unbound) warfarin and
amiodarone, which increases actions of both drugs
(harmful)
Metabolism
erythromycin with cyclosporine
Both drugs compete for the same
liver enzymes
Decreased metabolism of cyclosporine, possibly
resulting in toxic levels of cyclosporine (harmful)
Excretion
amoxicillin with probenecid
Inhibits the secretion of amoxicillin
into the kidneys
Elevates and prolongs the plasma levels of amoxicillin
(can be beneficial)
of drug interactions is vital for the appropriate monitoring
of drug therapy. The more drugs a patient receives, the more
likely that a drug interaction will occur. This is especially true
in older adults, who typically have an increased sensitivity to
drug effects and are receiving several medications. In addition,
over-the-counter medications and natural health products can
interact significantly with prescribed medications. Food also
can interact significantly with certain drugs. See Table 2.9 for
the most common food and drug interactions.
Alteration of the action of one drug by another is referred to
as drug interaction. A drug interaction can either increase or
decrease the actions of one or both involved drugs. Drug interactions can be either beneficial or harmful. Numerous drug
interactions can occur and have been reported. Please note that
only those drug interactions that are considered to be significant—with at least a high probability of occurring—or those
that require dosage or therapy adjustment are discussed in this
textbook. An authoritative resource may be used as a means of
exploring all possible drug interactions.
Concurrently administered drugs may interact with each
other and alter the pharmacokinetics of one another during any
of the four phases of pharmacokinetics: absorption, distribution, metabolism, or excretion. Table 2.9 provides examples of
drug interactions during each of these phases. Most commonly,
drug interactions occur when there is competition between two
drugs for metabolizing enzymes, such as the cytochrome P450
enzymes listed in Table 2.5. As a result, the speed of metabolism
of one or both drugs may be enhanced or reduced. This change
in metabolism of one or both drugs can lead to subtherapeutic
or toxic drug actions.
Many terms are used to categorize drug interactions. When
two drugs with similar actions are given together, they can
have additive effects. This means that the combined effects of
the drugs combine such that if two drugs of similar action are
administered at the same time, the action of one plus the action
of the other results in the total effect of both drugs being given.
This can be represented by 1 + 1 = 2 (summation of effects).
Examples are the many combinations of analgesic products,
such as acetylsalicylic acid and opioid combinations (acetylsalicylic acid and codeine) and acetaminophen and opioid combinations (acetaminophen and oxycodone). The total analgesic
effect of both drugs results. Often drugs are used together for
their additive effects so that smaller doses of each drug can be
given.
Synergistic effects occur when the action of one drug
enhances the action of another. The two drugs administered
together interact in such a way that their combined effects are
greater than the sum of the effects for each drug given alone (1
+ 1 = greater than 2). The combination of hydrochlorothiazide
with lisinopril for the treatment of hypertension is one example. It is important to remember that synergistic effects can also
result in dangerous effects—for example, the combination of
alcohol and acetaminophen may result in liver damage.
Antagonistic effects are said to occur when the combination of two drugs results in drug effects that are less than the
sum of the effects for each drug given separately (1 + 1 = less
than 2). An example of this type of interaction occurs when
the antibiotic ciprofloxacin is given simultaneously with antacids, vitamins, iron, or dairy products. These drugs reduce the
absorption of ciprofloxacin and lead to decreased effectiveness
of the antibiotic.
Incompatibility is a term most commonly used to describe
parenteral drugs. Drug incompatibility occurs when two parenteral drugs or solutions are mixed together, and the result is
a chemical deterioration of one or both of the drugs. The combination of two such drugs usually produces a precipitate, haziness, or colour change in the solution. Before administering any
intravenous medication, the nurse must always inspect the bag
for precipitate. If the solution appears cloudy or if visible flecks
are seen, the bag must not be given to the patient and must be
discarded. An example of incompatible drugs is the combination of parenteral furosemide and heparin sodium.
Adverse Drug Events
The recognition of the potential hazards and actual detrimental effects of medication use is a topic that continues to receive
much attention in the literature. This focus has contributed to
an increasing body of knowledge regarding this topic as well as
the development of new terminology. Health care institutions
are also under increasing pressure to develop effective strategies
for preventing adverse effects of drugs.
Adverse drug event (ADE) is a broad term for any undesirable occurrence involving medications. A similarly broad
term seen in the literature is drug misadventure. Patient
32
PART 1 Pharmacology Basics
outcomes associated with ADEs vary from no effects or mild
discomfort to life-threatening complications, permanent disability, disfigurement, or death. ADEs can be preventable (see
discussion of medication errors [MEs] later in Chapter 6) or
nonpreventable. Fortunately, many ADEs result in no measurable patient harm. ADEs can be both external and internal.
The most common causes of ADEs external to the patient are
errors by caregivers (both professional and nonprofessional)
and malfunctioning of equipment (e.g., intravenous infusion
pumps). An ADE can be internal, or patient induced, such as
when a patient fails to take medication as prescribed or drinks
alcoholic beverages that he was advised not to consume while
taking a given medication. An impending ADE that is noticed
before it actually occurs is considered a potential ADE (and
appropriate steps should be taken to avoid such a “near miss”
in the future). A less common situation, but one still worth
mentioning, is an adverse drug withdrawal event. This is an
adverse outcome associated with discontinuation of drug therapy, such as hypertension caused by abruptly discontinuing
blood pressure medication or return of infection caused by
stopping antibiotic therapy too soon.
The two most common broad categories of ADEs are
medication errors and adverse drug reactions. A medication
error (ME) is a preventable situation in which there is a compromise in the Ten Rights of medication use: right patient,
right drug, right time, right route, right dose, right documentation, right reason, right patient education, right to
refuse, and right assessment or evaluation. (See Preventing
Medication Errors box on page 23.) MEs are more common
than adverse drug reactions. MEs occur during the prescribing, dispensing, administering, or monitoring of drug
therapy. These four phases are collectively known as the
medication use process. See Chapter 6 for further discussion of MEs.
An adverse drug reaction (ADR) (see Chapter 6) is any
reaction to a drug that is unexpected and undesirable and
occurs at therapeutic drug dosages. ADRs may or may not be
caused by MEs. ADRs may result in hospital admission, prolongation of hospital stay, change in drug therapy, initiation
of supportive treatment, or complication of a patient’s disease state. ADRs are caused by processes inside the patient’s
body. They may or may not be preventable, depending on the
situation. Mild ADRs (e.g., drug adverse effects—see later in
this chapter) usually do not require a change in the patient’s
drug therapy or other interventions. More severe ADRs, however, are likely to require changes to a patient’s drug regimen.
Severe ADRs can be permanently or significantly disabling,
life threatening, or fatal. They may require or prolong hospitalization, lead to organ damage (e.g., to the liver, kidneys,
bone marrow, skin), cause congenital anomalies, or require
specific interventions to prevent permanent impairment or
tissue damage.
ADRs that are specific to drug groups are discussed in the
corresponding drug chapters in this book. Four general categories are discussed here: pharmacological reaction, hypersensitivity (allergic) reaction, idiosyncratic reaction, and drug
interaction.
A pharmacological reaction is an extension of the drug’s
normal effects in the body. For example, a drug that is used
to lower blood pressure in a patient causes a pharmacological
ADR when it lowers the blood pressure to the point at which the
patient becomes unconscious.
Pharmacological reactions that result in adverse effects are
predictable, well-known ADRs resulting in minor or no changes
in patient management. They have predictable frequency and
intensity, and their occurrence is a result of the dose. They also
usually resolve with a change in dose or discontinuation of drug
therapy.
An allergic reaction (also known as a hypersensitivity
reaction) involves the patient’s immune system. Immune system proteins known as immunoglobulins recognize the drug
molecule, its metabolite(s), or another ingredient in a drug
formulation as a dangerous foreign substance. At this point,
an immune response may occur in which immunoglobulin
proteins bind to the drug substance to neutralize the drug.
Various chemical mediators, such as histamine, as well as
cytokines and other inflammatory substances (e.g., prostaglandins [Chapter 38]), usually are released during this process. This response can range from mild reactions such as
skin erythema or mild rash to severe or even life-threatening reactions such as constriction of bronchial airways and
tachycardia.
It can be assumed throughout this textbook that use of any
drug is contraindicated if the patient has a known allergy to that
specific drug product. Allergy information may be reported by
patients as part of their history or may be observed by health
care providers during a patient encounter. In either case, every
effort must be made to document as fully as possible the name
of the drug product and the degree and details of the adverse
reaction that occurred—for example, “Penicillin; skin rash, pruritus” or “Penicillin; urticaria and anaphylactic shock requiring
emergency intervention.”
In more extreme cases of disease or injury (e.g., cancer,
snakebite), it may be deemed reasonable to administer a given
drug despite a reported allergic or other adverse reaction. In
such cases, the patient will likely be premedicated with additional medications (e.g., acetaminophen [Tylenol ], diphenhydramine Benadryl ], prednisone) in an attempt to control
any adverse reactions that may occur.
An idiosyncratic reaction is not the result of a known pharmacological property of a drug or patient allergy but instead
occurs unexpectedly in a particular patient. Such a reaction is
a genetically determined abnormal response to ordinary doses
of a drug. The study of such traits, which are solely revealed by
drug administration, is called pharmacogenetics (see Chapter
5). Idiosyncratic drug reactions are usually caused by a deficiency or excess of drug-metabolizing enzymes. Many pharmacogenomic disorders exist, for example, glucose-6-phosphate
dehydrogenase (G6PD) deficiency.
People who lack proper levels of G6PD have idiosyncratic reactions to a wide range of drugs (see Ethnocultural
Implications box). There are more than 80 variations of
the disease, and all produce some degree of drug-induced
hemolysis.
®
®
CHAPTER 2 Pharmacological Principles
ETHNOCULTURAL IMPLICATIONS
Glucose-6-Phosphate Dehydrogenase Deficiency
Globally, glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most
common enzyme defect. It is found predominantly in African, Middle Eastern,
and South Asian populations. G6PD is an enzyme found in abundant amounts
in the tissues of most individuals. It reduces the risk of hemolysis of red blood
cells when they are exposed to oxidizing drugs such as acetylsalicylic acid.
G6PD deficiency is inherited as an X-linked, recessive condition; consequently,
the condition usually occurs in boys. Drugs to avoid in patients with G6PD
deficiency are nitrofurantoin, primaquine, probenecid, and sulfonamides.
The final type of ADR is due to drug interaction. As
described earlier, drug interaction occurs when the simultaneous presence of two (or more) drugs in the body produces an
unwanted effect. This unwanted effect can result when one drug
either accentuates or reduces the effects of another drug. Some
drug interactions are intentional and beneficial (see Table 2.9).
However, most clinically significant drug interactions are harmful. Drug interactions specific to drugs are discussed in detail in
the chapters dealing with those drugs.
Other Drug Effects
Other drug-related effects that must be considered during
therapy are teratogenic, mutagenic, and carcinogenic effects.
These can result in devastating patient outcomes and in many
instances can be prevented by appropriate monitoring.
Teratogenic effects of drugs or other chemicals result in structural defects in the fetus. Compounds that produce such effects
are called teratogens. Prenatal development involves a delicate
program of interrelated embryological events. Any significant
disruption in this process of embryogenesis can have a teratogenic effect. Drugs that are capable of crossing the placenta can
cause drug-induced teratogenesis. Drugs administered during
pregnancy can produce different types of congenital anomalies.
The period during which the fetus is most vulnerable to teratogenic effects begins with the third week of development and usually ends after the third month. Chapter 4 describes the Health
Canada safety classification for drugs used by pregnant women.
Mutagenic effects are permanent changes in the genetic
composition of living organisms and consist of alterations in
the chromosome structure, the number of chromosomes, or
the genetic code of the deoxyribonucleic acid (DNA) molecule.
Drugs that are capable of inducing mutations are called mutagens. Radiation, viruses, chemicals (e.g., industrial chemicals
such as benzene), and drugs can all act as mutagenic agents in
human beings. Drugs that affect genetic processes are active primarily during cell reproduction (mitosis).
Carcinogenic effects are the cancer-causing effects of drugs,
other chemicals, radiation, and viruses. Agents that produce
such effects are called carcinogens. Some exogenous causes of
cancer are listed in Box 2.3.
PHARMACOGNOSY
Plants are an important and long-established resource of preparations used in medicine. Pharmacognosy involves the process
BOX 2.3
33
Exogenous Carcinogens
Dietary customs
Drug misuse
Carcinogenic drugs
Workplace chemicals
Radiation
Environmental pollution
Food-processing procedures
Food-production procedures
Oncogenic viruses
Smoking
of identifying medicinal plants and their ingredients, pharmacological effects, and therapeutic efficacy. Although many drugs
in current use are synthetically derived, most were first isolated
in nature. For example, almost all major groups of wild plants
in Canada have edible members that are reported to have been
used by indigenous people. Algae (e.g., seaweed), fungi (e.g.,
mushrooms), and roots are commonly used for their medicinal purposes. The four main sources for drugs are plants, animals, minerals, and laboratory synthesis. Plants provide many
weak acids and weak bases (alkaloids) that are useful and potent
drugs. Alkaloids are more common, including atropine (belladonna plant), caffeine (coffee bean), and nicotine (tobacco leaf).
Animals are the source of many hormone drugs. Conjugated
estrogens are derived from the urine of pregnant mares, hence
the drug trade name Premarin. Equine is the term used for any
horse-derived drug. Insulin comes from two sources: pigs (porcine) and humans. Human insulin is now far more commonly
used than animal insulins thanks to the use of recombinant
DNA techniques. Heparin sodium is another commonly used
drug that is derived from pigs (porcine heparin). Some common mineral sources of currently used drugs are salicylic acid,
aluminum hydroxide, and sodium chloride.
PHARMACOECONOMICS
Pharmacoeconomics is the study of the economic factors influencing the cost of drug therapy. One example is performing a
cost–benefit analysis of one antibiotic versus another when
competing drugs are considered for inclusion in a hospital formulary. Such studies typically examine treatment outcomes
data (e.g., how many patients recovered and how soon) in relation to the comparative total costs of treatment with the drugs
in question.
TOXICOLOGY
The study of poisons and unwanted responses to both drugs
and other chemicals is known as toxicology. Toxicology is the
science of the adverse effects of chemicals on living organisms.
Clinical toxicology deals specifically with the care of patients
who have been poisoned. Poisoning can result from a variety
of causes, ranging from drug overdose to ingestion of household cleaning agents to snakebite. Poison control centres are
health care institutions equipped with sufficient personnel and
34
PART 1 Pharmacology Basics
information resources to recommend appropriate treatment for
poisoning. They are usually staffed with specially trained pharmacists, nurses, and physicians who triage incoming calls and
refer complex cases to clinical toxicologists.
Effective treatment for poisoning is based on a system of priorities, the first of which is to preserve the patient’s vital functions by maintaining airway, breathing, and circulation. The
second priority is to prevent absorption of the toxic agent or
speed its elimination from the body using one or more clinical
methods available. Several common poisons and their specific
antidotes are listed in Table 2.10.
SUMMARY
A thorough understanding of pharmacological principles
of pharmacokinetics, pharmacodynamics, pharmacotherapeutics, and toxicology is essential in drug therapy and for
safe, quality nursing practice. Medications may be helpful in
treating disease, but unless the nurse has an adequate, up-todate knowledge base and clinical skills and engages in critical thinking and good decision making, any treatment may
become harmful. Application of pharmacological principles
enables the nurse to provide safe and effective drug therapy
Common Causes of Poisoning
and Their Antidotes
TABLE 2.10
Substance
Antidote
Acetaminophen
Acetylcysteine
Organophosphates (e.g., insecticides)
Atropine
Tricyclic antidepressants, quinidine
Sodium bicarbonate
Iron salts
Deferoxamine
Digoxin and other cardiac glycosides
Digoxin antibodies
Ethylene glycol (e.g., automotive
antifreeze solution), methanol
Ethanol (same as alcohol used
for drinking), administered
intravenously
Benzodiazepines
Flumazenil
β-blockers
Glucagon
Opiates, opioid drugs
Naloxone
Carbon monoxide (by inhalation)
Oxygen (at high concentrations),
known as bariatric therapy
while always acting on behalf of the patient and respecting
the patient’s rights. Nursing considerations associated with
various routes of drug administration are summarized in
Table 2.3.
KEY POINTS
• The following drug therapy definitions are important to
remember: pharmacology—the study or science of drugs;
pharmacokinetics—the study of drug distribution among
various body compartments after a drug has entered the
body, including the phases of absorption, distribution,
metabolism, and excretion; and pharmaceutics—the science
of dosage form design.
• The nurse’s role in drug therapy and the nursing process is
more than just memorizing the names of drugs, their uses,
and associated interventions. It involves a thorough comprehension of all aspects of pharmaceutics, pharmacokinetics,
and pharmacodynamics and the sound application of this
drug knowledge to a variety of clinical situations. Refer to
Chapter 1 for more detailed discussion of drug therapy as it
relates to the nursing process.
• Drug actions are a result of the pharmacological, pharmaceutical, pharmacokinetic, and pharmacodynamic properties of a given medication, and each of these has a specific
influence on the overall effects produced by the drug in a
patient.
• Selection of the route of administration is based on patient
variables and the specific characteristics of the drug.
• Nursing considerations vary depending on the drug as well
as the route of administration.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. An older adult woman took a prescription medicine to help
her to sleep; however, she felt restless all night and did not
sleep at all. The nurse recognizes that this woman has experienced which type of reaction or effect?
a. Allergic reaction
b. Idiosyncratic reaction
c. Mutagenic effect
d. Synergistic effect
2. While caring for a patient with cirrhosis or hepatitis, the
nurse knows that abnormalities in which phase of pharmacokinetics may occur?
a. Absorption
b. Distribution
c. Metabolism
d. Excretion
3. A patient who has advanced cancer is receiving opioid medications around the clock to “keep him comfortable” as he
nears the end of his life. Which term best describes this type
of therapy?
a. Palliative therapy
b. Maintenance therapy
c. Supportive therapy
d. Supplemental therapy
4. The nurse is giving medications to a patient in heart failure.
The intravenous route is chosen instead of the intramuscular route. Which patient factor most influences the decision
about which route to use?
a. Altered biliary function
b. Increased glomerular filtration
c. Reduced liver metabolism
d. Diminished circulation
CHAPTER 2 Pharmacological Principles
5. A patient has just received a prescription for an enteric-coated
stool softener. When teaching the patient, the nurse should
include which statement?
a. “Take the tablet with 60 to 90 mL of orange juice.”
b. “Avoid taking all other medications with any entericcoated tablet.”
c. “Crush the tablet before swallowing if you have problems
with swallowing.”
d. “Be sure to swallow the tablet whole without chewing it.”
6. Each statement describes a phase of pharmacokinetics. Put
the statements in order, with 1 indicating the phase that
occurs first and 4 indicating the phase that occurs last.
a. Enzymes in the liver transform the drug into an inactive
metabolite.
b. Drug metabolites are secreted through passive glomerular filtration into the renal tubules.
35
c. A drug binds to the plasma protein albumin and circulates through the body.
d. A drug moves from the intestinal lumen into the mesenteric blood system.
7. A drug that delivers 500 mg has a half-life of 4 hours. How
many milligrams of drug will remain in the body after 1 halflife?
8. The nurse is reviewing the various forms of topical medications. Which of these are considered topical medications?
(Select all that apply.)
a. Rectal ointment for hemorrhoids
b. Eye drops for inflammation
c. Sublingual tablet for chest pain
d. Inhaled medication for asthma
e. Intradermal injection for tuberculosis testing
CRITICAL THINKING ACTIVITIES
1. A patient tells the nurse during the assessment that he experiences some “strange” problem with drug metabolism that
he was born with, so he is not to take certain medications.
What type of disorder is this patient referring to, and what
are the problems it can cause in the patient when specific
medications are taken? What is the nurse’s priority action
when a patient shares this information?
2. Charles is admitted to the trauma unit with multisystem
injuries from an automobile accident. He arrived at the unit
with multiple abnormal findings, including shock from
blood loss, decreased cardiac output, and urinary output of
less than 30 mL/hr. Which route of administration would
you expect to be the best choice for this patient? Explain your
answer.
3. You are administering medications to a patient who had an
enteral tube inserted 2 days earlier for continuous feedings.
As you review the medication list, you note that one drug
is an enteric-coated tablet ordered to be given twice a day.
What is the best action regarding giving this drug to this
patient?
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
REFERENCE
Website
•
•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
Government of Canada. (2019). Controlled Drugs and Substances
Act S.C. 1996, c. 19 – amended 2019/05/15. Retrieved from https://
laws-lois.justice.gc.ca/eng/acts/C-38.8/.
3
Legal and Ethical Considerations
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Briefly discuss the important components of drug
legislation at the provincial and federal levels.
2. Provide examples of how drug legislation impacts drug
therapy, professional nursing practice, and the nursing
process.
3. Discuss the various categories of controlled substances, and
provide specific drug examples in each category.
4. Identify the process involved in the development of new
drugs, including the investigational new drug application,
the phases of investigational drug studies, and the process
for obtaining informed consent.
5. Discuss the ethical principles of drug administration and
how they apply to pharmacology and the nursing process.
6. Identify the principles involved in making an ethical
decision.
7. Develop a collaborative care plan that addresses the legal
and ethical care of patients, with a specific focus on drug
therapy and the nursing process.
KEY TERMS
Bias Any systematic error in a measurement process. One
common effort to avoid bias in research studies involves the
use of blinded study designs. (p. 41)
Benzodiazepines and Other Targeted Substances
Regulations Implemented in 2000, these regulations
specify the requirements for producing, assembling,
importing, exporting, selling, providing, transporting,
delivering, or destroying benzodiazepines and other
targeted substances. (p. 39)
Blinded investigational drug study A research design in
which subjects in the study are purposely made unaware
of whether the substance they are administered is the drug
under study or a placebo. This method serves to minimize
bias on the part of research subjects in reporting their
body’s responses to investigational drugs. (p. 41)
Canada Health Act Canada’s federal legislation for publicly
funded health care insurance. (p. 42)
Controlled Drugs and Substances Act (CDSA) A Health
Canada act that makes it a criminal offence to possess, traffic,
produce, import, or export controlled substances. (p. 39)
Controlled substances Any drugs listed on one of the
“schedules” of the Controlled Drugs and Substances Act (also
called a scheduled drug if it is an item under the Food and
Drug Regulations Part G). (p. 39)
Double-blind, investigated drug study A research design
in which both the study investigator(s) and the subjects
are purposely made unaware of whether the substance
administered to a given subject is the drug under study or
a placebo. This method minimizes bias on the part of both
the investigator and the subject. (p. 41)
Drug Identification Number (DIN) A computer-generated
number assigned by Health Canada, placed on the label of
36
prescription and over-the-counter drug products that have
been evaluated by the Therapeutic Products Directorate
(TPD) and approved for sale in Canada. (p. 40)
Ethics A set of principles, rights and responsibilities, and
duties governing the moral values, beliefs, actions, and
behaviours of human conduct and the rules and principles
that ought to govern them. (p. 44)
Food and Drugs Act The main piece of drug legislation in
Canada that protects consumers from contaminated,
adulterated, and unsafe drugs and labelling practices; also
addresses appropriate advertising and selling of drugs,
foods, cosmetics, and therapeutic devices. (p. 38)
Food and Drug Regulations An adjunct to the Food and
Drugs Act, these regulations clarify terms used in the Act
and state the processes that companies must carry out to
comply with the Act in terms of importing, preparing,
treating, processing, labelling, advertising, and selling foods,
drugs, cosmetics, natural health products including herbal
products, and medical devices. (p. 38)
Informed consent Written permission obtained from a
patient consenting to a specific procedure (e.g., receiving
an investigational drug), after the patient has been given
information regarding the procedure deemed necessary for
the patient to make a sound or “informed” decision. (p. 40)
Investigational new drug (IND) A drug not yet approved
for marketing by the Therapeutic Products Directorate
of Health Canada but available for use in experiments to
determine its safety and efficacy. (p. 40)
Investigational new drug application An application that
must be submitted to the Therapeutic Products Directorate
of Health Canada before a drug can be studied in humans.
(p. 40)
CHAPTER 3 Legal and Ethical Considerations
Malpractice A special type of negligence or the failure of a
professional or individual with specialized education and
training to act in a reasonable and prudent way. (p. 43)
Negligence The failure to act in a reasonable and prudent
manner or failure of the nurse to give the care that a
reasonably prudent (cautious) nurse would render or use
under similar circumstances. (p. 43)
New drug submission The type of application that a drug
manufacturer submits to the Therapeutic Products
Directorate of Health Canada following successful
completion of required human research studies. (p. 41)
Notice of Compliance A notification issued when Health
Canada decides that a drug and its manufacturing process
are safe and effective, allowing the pharmaceutical company
to sell the product by prescription to the Canadian
population. (p. 40)
Placebo An inactive (inert) substance (e.g., saline, distilled
water, starch, sugar) that is not a drug but is formulated to
resemble a drug for research purposes. (p. 41)
LEGAL CONSIDERATIONS
Prescription drug use is vital to treating and preventing illness.
However, due to safety reasons, its use is regulated and enforced
by several different agencies, including Health Canada, the Royal
Canadian Mounted Police (RCMP), and individual provincial
or territorial laws. Traditionally, only medical doctors and doctors of osteopathy had the privilege of prescribing medications.
Dentists and podiatrists are also allowed to prescribe medications so long as it is within the scope of their practice. In some
provinces or territories, other health care providers may also prescribe, including licensed physician’s assistants, pharmacists, and
nurse practitioners. In 2015, the Canadian Nurses Association
(CNA, 2015) created a framework for RN prescribing in Canada.
Based on this beginning framework, both the College and
Association of Registered Nurses of Alberta (CARNA) and the
College of Nurses of Ontario (CNO) have created standards for
educating nurses to prescribe medications and order diagnostic tests in specialty clinical areas. As of May 1, 2019, registered
nurses in Alberta who work in specialty areas have had the ability
to prescribe certain medications and order diagnostic tests.
As the number and complexity of prescriptions continue to
increase and technology continually changes, so do the laws
regarding their use. With the ever-changing role of the professional nurse and other members of the health care team, and with
the increasing pace of technologic advances, each role becomes
more complex. Professional nurses have gained even more autonomy over their nursing practice. With this increasing autonomy
comes greater liability and legal accountability; therefore, professional nurses must be aware and duly consider this responsibility
as they practise. Specific laws and regulations are discussed later.
Canadian Drug and Related Legislation
Concerns over the sale and use of foods, drugs, cosmetics, and
medical devices began in Canada long before such concerns
37
Precursor Control Regulations A scheme intended to allow
Canada to fulfill its international obligations and meet
its domestic needs with respect to the monitoring and
control of precursor chemicals such as methamphetamine,
gamma-hydroxybutyric acid (GHB), and other drugs
listed in Schedules I, II, and III of the Controlled Drugs
and Substances Act, across Canadian borders and within
Canada. (p. 39)
Priority Review of Drug Submissions A Health Canada
policy that allows for earlier review of drug products for
serious, life-threatening, or severely debilitating diseases
or conditions for which there is no effective drug on the
Canadian market. (p. 40)
Special Access Programme A program that allows health care
providers to apply for access to drugs currently unavailable
for sale in Canada. (p. 41)
arose in the United States. Canadian drug legislation began
in 1875, when the Parliament of Canada passed an act to prevent the sale of adulterated foods, drinks, and drugs. Since
that time, food and drugs have been controlled on a national
basis. The Health Products and Food Branch Inspectorate
(HPFB) of Health Canada is the federal regulator responsible
for the administration and enforcement of the Food and Drugs
Act and Food and Drug Regulations, as well as the Controlled
Drugs and Substances Act, the two Acts that form the underlying foundation for the drug laws in Canada. The Therapeutic
Products Directorate (TPD) is the Canadian federal authority
that regulates these Acts. These Acts are designed to protect the
Canadian consumer from potential health hazards and fraud or
deception in the sale and use of foods, drugs, cosmetics, and
medical devices.
The Personal Information Protection and Electronic Documents
Act (PIPEDA) is federal law governing the collection, use, and
disclosure of personal information. Several provinces and territories have legislation that deals specifically with the collection, use, and disclosure of personal health information by
health care providers and health care organizations. For example, Ontario has the Personal Health Information Protection Act
(PHIPA) of 2004, while British Columbia has the Personal Health
Information Access and Protection of Privacy Act of 2008. Such
acts require all health care providers, health insurance and life
insurance companies, public health authorities, employers, and
schools to maintain patient privacy regarding protected health
information. Protected health information includes any individually identifying information such as patients’ health conditions, account numbers, prescription numbers, medications,
and payment information. Such information can be oral or
recorded in any paper or electronic form. In 2013, a proposal
was introduced to revise PHIPA to the Electronic Personal Health
Information Protection Act (EPHIPA), intended to address the
38
PART 1 Pharmacology Basics
TABLE 3.1
Additions to the Food and Drugs Act
Schedule
Description
Schedules C and D
Drugs in these schedules must list where the drug was manufactured and the process and conditions of manufacturing.
Prescription Drug List
Replaces Schedule F. This is a list of medicinal ingredients in a drug that requires a prescription. Excluded are drugs listed in
the Controlled Drugs and Substances Act schedules that require a prescription.
Part G
These drugs, also known as controlled drugs, affect the central nervous system (CNS); labels on these drugs are marked C.
Controlled drugs are categorized into three parts:
Part I: designated controlled drugs with misuse potential that may be used for designated medical conditions outlined in Food
and Drug Regulations. Examples: amphetamines, methylphenidate, pentobarbital, preparations containing one controlled
drug and one or more active noncontrolled drug
Part II: controlled drugs with misuse potential prescribed for medical conditions. Examples: sedatives such as barbiturates and
derivatives (e.g., secobarbital), thiobarbiturates (e.g., pentothal sodium)
Part III: controlled drugs with misuse potential. Examples: anabolic steroids (e.g., androstanolone), weight reduction drugs
(anorexiants)
Narcotic Drugs and Preparations
Drugs with high-misuse potential. Examples: morphine, codeine more than 8 mg, amidones (e.g., methadone), coca and derivatives (e.g., cocaine), benzazocines (analgesics such as pentazocine), fentanyls
Part J
These are restricted drugs with high-misuse potential, dangerous physiological and psychological adverse effects, and no
recognized medical use. Examples: lysergic acid diethylamide (LSD), mescaline (peyote), harmaline, psilocin and psilocybin
(magic mushrooms)
Benzodiazepines and Other
Targeted Substances
Regulations
A “targeted substance” is either a controlled substance that is included in Schedule I or a product or compound that contains
a controlled substance that is included in Schedule I. These are drugs with misuse potential. Examples: benzodiazepine
tranquilizers such as diazepam, lorazepam, flunitrazepam, zolpidem
technological realities of electronic health records. The primary
purpose of federal legislation is to ensure the safety and efficacy
of new drugs and, in the case of privacy laws, to protect patient
confidentiality.
Canadian Food and Drugs Act
The Canadian Food and Drugs Act is the primary piece of legislation governing foods, drugs, cosmetics, and medical devices
in Canada. The Act has been amended several times since its
inception in 1953. Table 3.1 summarizes these amendments.
Schedule A of the Act lists the diseases for which treatments
may not be promoted to the public. Sections 3(1) and 3(2) of
the Food and Drugs Act prohibit any label claim or advertisement that is both directed to the general public and contains
treatment, preventative, or cure claims for Schedule A diseases.
Revisions to Schedule A came into force on June 1, 2008. The
updated Schedule A generally includes life-threatening diseases
such as cancer and acute forms of specific diseases. For example, “liver disease,” which covers all liver diseases, disorders,
and abnormalities, is now listed as “hepatitis,” which is a more
specific disease. The legend Canadian Standard Drug, or CSD,
must appear on the inner and outer labels of the drug packaging to show that a drug meets the standards for which it is
prescribed.
According to the Act, and to protect the consumer, drugs
must comply with official prescribed standards stated in recognized pharmacopoeias and formularies listed in Schedule B of
the Act. Recognized pharmacopoeias and formularies include
the following:
• Pharmacop e fran aise
• Pharmacopoeia Internationalis
• The British Pharmacopoeia
• The Canadian Formulary
• The National Formulary
• The Pharmaceutical Codex: Principles and Practices of Pharmaceuticals
• The United States Pharmacopoeia
Drugs listed in Schedule C are radiopharmaceuticals, and
drugs listed in Schedule D include allergenic substances, immunizing agents (vaccines), insulin, anterior pituitary extracts,
drugs obtained by recombinant DNA technology, and blood
derivatives. The distribution of drug samples, defined as trial
packages of medication, is also regulated, with the exception
of the distribution under prescribed conditions to physicians,
dentists, or pharmacists. All drugs that require a prescription
are listed in Schedule F, with the exception of narcotics and controlled drugs. Schedule F to the Food and Drug Regulations was
replaced by a list of prescription drugs called the Prescription
Drug List. The prescription status helps to ensure that consumers receive adequate risk and benefit information from a health
care provider before taking the drug. The Pr symbol in the
upper left quarter of the label—a black box with the letters Pr in
white, inside—identifies the product as a prescription drug. The
Food and Drugs Act also regulates the information manufacturers may put on a drug label, including directions for use. A prescription may be refilled as often as indicated by the prescriber.
Prescriptions are written (including facsimiles) or transmitted
orally (via telephone to the pharmacist) by a qualified health
care provider.
The Food and Drug Regulations are the current, consolidated regulations of the Food and Drugs Act. Parts G and J
regulate controlled drugs and restricted drugs, respectively.
Controlled drugs are dispensed only by prescription. A controlled drug must be marked with the symbol C in a clear
CHAPTER 3 Legal and Ethical Considerations
manner and in a conspicuous colour and size, in the upper left
quarter of the label. The proper name of the drug must also
appear on the label and either precede or follow the brand name
of the drug.
Controlled Drugs and Substances Act
The Controlled Drugs and Substances Act (CDSA) was passed
in 1997, replacing the Narcotic Control Act and Parts III and IV
of the Food and Drugs Act. The CDSA provides the requirements
for the control and sale of narcotics, controlled drugs, and substances of misuse (see Controlled Drugs and Substances Act,
https://laws-lois.justice.gc.ca/eng/acts/C-38.8/). Controlled
substances and substances for medical treatment may be legally
obtained only with a prescription from a licensed medical practitioner. The letter N and the symbol are printed on the label
of all controlled drugs. The CDSA is based on eight schedules
that list controlled drugs and substances based on potential
for misuse or harm or how easy they are to manufacture into
illicit substances. A summary of Schedule I contains the most
dangerous drugs, including opiates (opium, heroin, morphine,
cocaine), fentanyls, and methamphetamine. Schedule II contains synthetic cannabinoid receptor type 1 agonists. All other
cannabis-related drugs are now regulated under the Cannabis
Regulations and the Cannabis Act. Schedule III contains the
more dangerous drugs such as amphetamines and lysergic acid
diethylamide (LSD). Schedule IV contains drugs such as barbiturates and anabolic steroids, which are dangerous but have
therapeutic uses; a prescription is required for possession of
drugs listed in Schedule IV. Schedules V and VI contain precursors required to produce controlled substances. Schedules
VII and VIII contain amounts of cannabis and cannabis resin
required for charge and sentencing purposes. The factors that
determine the schedule under which a controlled substance
should be placed are international requirements, the dependence potential and likelihood of abuse of the substance, the
extent of its abuse in Canada, the danger it represents to the
safety of the public, and the usefulness of the substance as a
therapeutic agent. The RCMP is responsible for enforcing the
CDSA and related sections of the Criminal Code and exempts
members of police forces from sections of the CDSA for the
purpose of performing their duties.
The Benzodiazepines and Other Targeted Substances
Regulations specify similar restrictions in regard to benzodiazepines, their salts and derivatives, and other targeted
substances mentioned in Schedules I and II. The Precursor
Control Regulations, introduced in 2003, address the need
for the control of essential and precursor chemicals routinely
used in clandestine labs for the production of methamphetamine, ecstasy, and other Schedule III drugs. The Marihuana
Medical Access Program ended in March 2014; it was replaced
with the Marihuana for Medical Purposes Regulations, in 2015,
and was ultimately repealed by the Canadian government when
cannabis was legalized on October 17, 2018. The Cannabis
Act and Cannabis Regulations (the latter of which falls under
the Controlled Drugs and Substances Act, Food and Drugs Act,
and the Cannabis Act) address cannabis for medical purposes
and replaced the Access to Cannabis for Medical Purposed
39
Regulations (ACMPR). Individuals who use marihuana for
medical reasons and are authorized by their health care provider can access cannabis and other related cannabis products
(seeds, oils, and plants) in three ways: by buying direct from a
seller licensed by the federal government, by registering with
Health Canada to produce a prescribed amount of cannabis, or
by assigning a designate to produce the product on their behalf
(Government of Canada, 2018).
NEW DRUG DEVELOPMENT
The research into and development of new drugs is an ongoing process. The pharmaceutical industry is a multi-billion–
dollar industry. Pharmaceutical companies must continuously
develop new and better drugs to maintain a competitive edge.
The research required for the development of these new drugs
may take several years. Hundreds of substances are isolated
but never make it to market. Once a potentially beneficial drug
has been identified, the pharmaceutical company must follow
a systematic process before the drug can be sold on the open
market. This highly sophisticated process is regulated and carefully monitored by Health Canada. The primary purpose of
Health Canada’s TPD is to protect patients and ensure drug
effectiveness.
This system of drug research and development is one of the
most stringent in the world. It was developed out of concern
for patient safety and drug efficacy. Much time, funding, and
documentation are required to ensure that these two important
objectives are met. Many drugs are marketed and used in foreign countries long before they get approval for use in Canada.
Drug-related calamities are more likely to be avoided by this
more stringent drug approval system. The thalidomide tragedy
resulted from the use of a drug that was first marketed in Europe
and then made available for distribution in Canada. In March
1962, thalidomide, used for nausea and morning sickness in
pregnant women, was removed from the Canadian drug market
due to resulting extreme physical malformations in newborns.
A balance must be achieved between making new, life-saving therapies available and protecting consumers from potential
drug-induced adverse effects. In 2003, Canada introduced the
Natural Health Products Regulations. These regulations cover
natural health products such as vitamins and minerals, herbal
remedies, homeopathic medicines, traditional medicines (e.g.,
traditional Chinese medicines), probiotics, and other products
such as amino acids and essential fatty acids (e.g., omega-3). The
manufacturer’s primary obligation regarding such products is to
not make “false or misleading” claims about their efficacy. For
example, a product label may read “For depression,” but cannot
read “Known to cure depression.” The availability of reliable,
objective information about these kinds of products is limited
but is growing as more formal research studies are conducted.
In 2008, Bill C-51 was drafted to complement and support the
current policies for foods and health products, including natural health products. Consumer demand for alternative medicine
products continues to drive this process. Patients must exercise
caution in using such products and communicate regularly with
their health care providers regarding their use.
40
PART 1 Pharmacology Basics
HEALTH CANADA DRUG APPROVAL PROCESS
The TPD of Health Canada is responsible for approving drugs
for clinical safety and efficacy before they are brought to the
market. There are stringent steps, each of which may take years,
that must be completed before the drug can be approved. The
TPD has made certain life-saving investigational drug therapies available sooner than usual by offering a priority review of
drug submissions process, also known as “fast-track” approval.
Eligible submissions undergo a shorter review target of 180 days,
compared to 300 days for non-priority submissions. Acquired
immune deficiency syndrome (AIDS) was the first major public health crisis for which the TPD began granting expedited
drug approval. This process enabled pharmaceutical manufacturers to shorten the approval process and allowed prescribers
to give medications that showed promise during early Phase I
and Phase II clinical trials, to qualified patients with AIDS. In
such cases, when a trial continues to show favourable results,
the overall process of drug approval is hastened. The concept of
expedited drug approval became controversial after the manufacturer recall of the anti-inflammatory drug rofecoxib (Vioxx),
in 2004. This recall followed multiple case reports of severe
cardiovascular events, including fatalities, associated with the
use of this drug and concerns that the manufacturer withheld
information about the drug’s risks. This unfortunate example
has reduced the number of drugs approved via the expedited
approval process.
The drug approval process is quite complex and prolonged. It normally begins with preclinical testing phases,
which include in vitro studies (using tissue samples and cell
cultures) and animal studies. Clinical (human) studies follow the preclinical phase. There are four clinical phases (see
below). The drug is put on the market after Phase III is completed if an investigational new drug application submitted
by the manufacturer is approved by the TPD. Phase IV consists of postmarketing studies. The collective goal of these
phases is to provide information on the safety, toxicity, efficacy, potency, bioavailability, and purity of the new drug. A
Notice of Compliance is issued when Health Canada decides
that the drug and the manufacturing process are safe and
effective, allowing the pharmaceutical company to sell the
product by prescription to the Canadian population. Once
a drug is approved for sale, it is assigned a computer-generated Drug Identification Number (DIN) by Health Canada.
The DIN is placed on the label of prescription and over-thecounter (OTC) drug products.
Preclinical Investigational Drug Studies
Current medical ethics still require that all new drugs undergo
laboratory testing using both in vitro (cell or tissue) and animal studies before any testing in human subjects can be done.
In vitro studies include testing of the response of various types
of mammalian (including human) cells and tissues to different
concentrations of the investigational drug. Various types of cells
and tissues used for this purpose are collected from living or
dead animal or human subjects (e.g., surgical or autopsy specimens). In vitro studies help researchers determine early on if
a substance might be too toxic for human patients. Many prospective new drugs are ruled out for human use during this preclinical phase of drug testing. However, a small percentage of
the many drugs tested in this manner are referred for further
clinical testing in human subjects.
Four Clinical Phases of Investigational
Drug Studies
Before any testing on humans begins, the subjects must provide informed consent, and the consent must be documented.
Informed consent involves the careful explanation to the
human test patient or research subject of the purpose of the
study, the procedures to be used, the possible benefits, and the
risks involved. This explanation is followed by written documentation on a consent form. The informed consent document,
or consent form, must be written in language that is understood
by the patient and must be dated and signed by the patient and at
least one witness. Informed consent is always voluntary. By law,
informed consent must be obtained more than a given number
of days or hours before certain procedures are performed and
must always be obtained when the patient is fully mentally competent. The informed consent process may be carried out by a
nurse or other health care provider, depending on how a given
study is designed.
Medical ethics dictate that participants in experimental drug
studies be informed volunteers and not be coerced to participate
in any way. Therefore, informed consent must be obtained from
all patients (or their legal guardians) before they can be enrolled
in an investigational new drug (IND) study. Some patients
may have unrealistic expectations of the IND’s usefulness.
Often they have the misconception that because an investigational drug is new it must automatically be better than existing
forms of therapy. Other volunteers may be reluctant to enter the
study because they think they will be treated as “guinea pigs.”
Whatever the circumstances of the study, the research subjects
must be informed of all potential hazards as well as the possible
benefits of the new therapy. It must be stressed to all patients
that involvement in IND studies is voluntary and that any individual can either decline to participate or quit the study at any
time without affecting the delivery of any previously agreedupon health care services.
Phase I
Phase I studies usually involve small numbers of healthy subjects (normally fewer than 100) rather than those who have the
disease or ailment that the new drug is intended to treat. An
exception might be a study involving a toxic drug used to treat
a life-threatening illness. In this case, the only study subjects
might be those who already have the illness and for whom other
viable treatment options may not be available. The purpose of
Phase I studies is to determine the potential adverse effects, the
optimal dosage range, and the pharmacokinetics of the drug
(i.e., absorption, distribution, metabolism, and excretion) and
to determine if further testing is needed. Blood tests, urinalyses,
assessments of vital signs, and specific monitoring tests are also
performed. These trials usually last from a few days to a few
weeks.
CHAPTER 3 Legal and Ethical Considerations
Phase II
Phase II studies involve larger numbers of volunteers (usually around 100 to 300) who have the disease or ailment that
the drug is designed to diagnose or treat. Study participants
are closely monitored for the drug’s effectiveness and to identify any adverse effects. Therapeutic dosage ranges are refined
during this phase. If no serious adverse effects occur, the study
can progress to Phase III.
Phase III
Phase III studies involve larger numbers of patients (normally
1000 to 3 000), who are followed by medical research centres and
other types of health care facilities. The patients may be treated
at the centre or may be spread over a wider geographic area.
The purpose of this larger sample size is to provide information
about infrequent or rare adverse effects that may not have been
observed during previous, smaller studies. To enhance objectivity, many studies are designed to incorporate a placebo. A placebo is an inert substance that is not a drug (e.g., normal saline),
given to a portion of the research subjects to separate out the
real benefits of the investigational drug from the apparent benefits arising out of researcher or subject bias regarding expected
or desired results of the drug therapy. A study incorporating
a placebo is called a placebo-controlled study. If the study subject does not know whether the drug being administered is a
placebo or the investigational drug but the investigator does
know, the study is referred to as a blinded investigational drug
study. In most studies, neither the research staff nor the subjects being tested know which subjects are being given the real
drug and which are receiving the placebo. This method further
enhances the objectivity of the study results and is known as
a double-blind, investigational drug study because both the
researchers and the subjects are “blinded” to the actual identity
of the substance administered to a given subject. Both the drug
and placebo dosage forms given to patients often look identical,
except for a secret code that appears on the medication itself
or its container. At the completion of the study, this code is
revealed or broken to determine which study patients received
the drug and which were given the placebo. The code can also
be broken before study completion by the principal investigator
in the event of a clinical emergency that requires a determination of what individual patients received.
The three objectives of Phase III studies are to establish the
drug’s clinical effectiveness, safety, and dosage range. After
Phase III is completed, Health Canada’s TPD and Biologics
and Genetic Therapies Directorate (BGTD) receive a report
from the manufacturer, at which time the drug company submits a new drug submission. The approval of the application
paves the way for the pharmaceutical company to market the
new drug exclusively until the patent for the drug molecule
expires. As mandated by the Canadian Patent Act, this is normally 20 years after discovery of the molecule and includes
the 10- to 12-year period generally required to complete drug
research. Therefore, a new drug manufacturer typically has
8 to 10 years after drug marketing to recoup research costs,
which are usually in the hundreds of millions of dollars for a
single drug.
41
Phase IV
Phase IV studies are postmarketing studies voluntarily conducted by pharmaceutical companies to obtain further proof of
the therapeutic and adverse effects of the new drug. However,
these studies may be mandated by Health Canada. Data from
such studies are usually gathered for at least 2 years after the
drug’s release. Often these studies compare the safety and efficacy of the new drug with that of another drug in the same
therapeutic category. An example would be a comparison of a
new nonsteroidal anti-inflammatory drug with ibuprofen in the
treatment of osteoarthritis. Some medications make it through
all phases of clinical trials without causing any problems among
study patients. However, when they are used in the larger general population, severe adverse effects may appear for the first
time. If a pattern of severe reactions to a newly marketed drug
begins to emerge, Health Canada may request that the manufacturer of the drug issue a voluntary recall. The drug can still
be prescribed; however, the prescriber must be made aware of
the potential risk. If the drug manufacturer refuses to recall the
medication, and if the number or severity of reactions reaches
a certain level, then the Health Products and Food Branch
Inspectorate of Health Canada may seek court action to condemn the product and allow it to be seized by legal authorities. Such an action, in effect, becomes an involuntary recall on
behalf of the manufacturer. There are three designated classes of
drug recall, based on Health Canada’s response to postmarketing data for a given drug:
• Class I: The most serious type of recall—use of the drug
product carries a reasonable probability of serious adverse
health effects or death.
• Class II: Less severe—use of the drug product may result
in temporary or medically reversible health effects, but the
probability of lasting major adverse health effects is low.
• Class III: Least severe—use of the drug product is not likely
to result in any significant health problems.
Notification by Health Canada of a drug recall or drug warnings may be in the form of press releases, website announcements, or letters to health care providers. Health Canada’s
MedEffect website provides a voluntary program called
MedEffect Canada, in which professionals and consumers
are encouraged to report any adverse events seen with newly
approved drugs. The Government of Canada’s Recalls and Safety
Alerts Database is a current comprehensive list of advisories,
warnings, and recalls: http://www.hc-sc.gc.ca/dhp-mps/medeff/
advisories-avis/index-eng.php. Drug information of this kind is
continually evolving as new events are observed and reported
by clinicians and patients. Recommended actions change with
time, so use the most current information available along with
sound clinical judgement.
Special Access Programme
The Health Canada Special Access Programme allows health
care providers compassionate access to drugs unavailable for
sale in Canada. The Special Access Programme is limited to
those with serious or life-threatening conditions (e.g., intractable depression, epilepsy, transplant rejection, hemophilia and
other blood disorders, terminal cancer, and AIDS) who may
42
PART 1 Pharmacology Basics
require experimental drugs for compassionate reasons or on
an emergency basis when other conventional therapies have
failed. New regulations were introduced in October 2013 that
prevent special access to certain unauthorized controlled substances (e.g., products containing heroin, unauthorized forms
of cocaine, or other restricted drugs such as LSD, ecstasy, “magic
mushrooms,” and “bath salts.”)
Patient Access to and Costs of Prescription Drugs
The twenty-first century in Canada has seen rapid growth in prescription drug use and costs. High drug expenses in Canada are
a significant barrier for people to access prescription drugs outside of hospital. Law, Cheng, Dhalla, Heard, & Morgan (2012)
found evidence that suggests that out-of-pocket expenses for
drugs, occurring in one in ten Canadians, influence the decision
to not adhere to prescription medications. Canadians affected
are those with low incomes, those without drug benefits, and
those in poor health.
Prescription drugs are not covered under the Canada Health
Act. Patients must pay for a drug unless the drug is covered
by a private drug plan or a federal, provincial, or territorial
(F/P/T) drug plan. Most provincial plans provide for some costs
of drugs to those who are poor, older adults, those with catastrophic drug costs, and people with certain conditions (e.g.,
cancer, HIV/AIDS). The federal government provides coverage
for indigenous peoples (see Non-insured Health Benefits First
Nation and Inuit Health Branch: Drug Benefit list—January
2019). Each Canadian province and territory has a formulary
committee that decides which drugs are listed on its formulary
and reimbursed by the drug benefit health plan, which have
restricted access, and which are not covered. There is a wide
variety of access to prescription drugs across the country—
provincial and territorial drug plans vary in eligibility criteria,
drugs covered, and financing. For example, most drugs are paid
for, for patients age 65 and over; however they are required to
pay dispensing fees (such fees vary among pharmacies, based on
the patient’s drug coverage plan) and not all drugs are covered.
For example, there may not be coverage if a trade name drug is
prescribed rather than a generic drug. The decision for provinces and territories to list a drug is based on a variety of factors,
such as effectiveness analyses, cost, government priorities, and
patient advocacy. Some drugs may be restricted if they require
special monitoring or if the cost is high.
Drug Advertising
Drug advertising in Canada is regulated by Health Canada.
Direct-to-consumer advertising (such as ads in consumer magazines and on subways) is restricted to simply giving the names
of prescription drugs, but these ads do not make claims for
product effectiveness. (This is not the case in the United States.)
Advertisements in professional health care journals contain
claims and prescribing information. Advertising Standards
Canada (ASC) and the Pharmaceutical Advertising Advisory
Board (PAAB) review and clear advertisements according to
standards set by the Food and Drugs Act. Although the clearance procedure is voluntary, most companies comply with the
regulations.
BOX 3.1
Nurse Practice Acts
Nurse practice acts (NPAs) are regulatory laws that are instrumental in defining the scope of nursing practice and that protect public health, safety, and
welfare. Nursing practice in Canada is regulated by separate acts in each of
the 10 provinces and 3 territories. These acts grant self-governance to the
nursing profession, direct entry into nursing practice, define the scopes of
practice, and identify disciplinary actions. NPAs are the most significant part
of legislation in regard to professional nursing practice. Together, it is NPAs
and common law that define nursing practice. Each province and territory has
a website on which the NPAs are defined and outlined. For example, for nurses
practising in New Brunswick or British Columbia, the websites are, respectively: http://www.nanb.nb.ca/ and https://www.bccnp.ca/Pages/Default.
aspx.
LEGAL NURSING CONSIDERATIONS
AND DRUG THERAPY
Provincial and territorial legislation dictates the boundaries for
professional nursing practice. Nursing practice standards of
care and nurse practice acts identify the definition of the scope
and role of the professional nurse (Box 3.1). Nurse practice
acts further define/identify: (1) the scope of nursing practice,
(2) expanded nursing roles, (3) educational requirements for
nurses, (4) standards of care, (5) minimally safe nursing practice, and (6) differences between nursing and medical practice.
In addition, provincial/territorial regulatory bodies of nursing
define specific nursing practices such as guidelines concerning
the administration of intravenous therapy. Additionally, guidelines from professional nursing groups (e.g., CNA), nursing
specialty groups, institutional policies and procedures, and provincial/territorial hospital licensing laws all help to identify the
legal boundaries of nursing practice. There is also case law or
common law, consisting of prior court rulings that affect professional nursing practice.
The CNA advances the practice and profession of nursing
to improve health outcomes and strengthen Canada’s health
care system. The CNA is the national voice for nurses and has
developed standards for nursing practice, policy statements,
and similar resolutions. The standards describe the scope, function, and role of the nurse and establish clinical practice standards. Accreditation Canada requires that accredited hospitals
fulfill certain standards in regard to nursing practice. One such
requirement is that these institutions must have written policies and procedures. These policies and procedures are usually
quite specific and are contained in policy and procedures manuals found on most nursing units, although many organizations
now post their policies not only internally, on the intranet, but
also externally, via the internet. The nurse must know the policies and procedures of the employing institution because if the
nurse is involved in a lawsuit, these policies and procedures
are one of the standards by which the nurse will be measured.
Nursing specialty organizations also define standards of care
for nurses who are certified in specialty areas, such as oncology,
surgical care, or critical care. Standards of care help to determine whether a nurse is acting appropriately when performing professional duties. It is critical to safe nursing practice to
CHAPTER 3 Legal and Ethical Considerations
BOX 3.2
Nurses
Areas of Potential Liability for
Area
Failure to ensure safety
Medication errors
Failure to assess/evaluate
Examples Regarding Drug Therapy
and the Nursing Process
Lack of adequate monitoring; failure to identify
patient allergies and other risk factors
regarding medication therapy; inappropriate
drug administration technique; failure to
implement appropriate nursing actions
based on a lack of proper assessment of
patient’s condition
Failure to clarify unclear medication order;
failure to identify and react to adverse
drug reactions; failure to be familiar with
medication prior to its administration; failure
to maintain level of professional nursing
skills for current practice; failure to identify
patient’s identity prior to drug administration; failure to document drug administration
in medication profile
Failure to see significant changes in patient’s
condition after taking a medication; failure to
report the changes in condition after medication; failure to take a complete medication
history and nursing assessment/history;
failure to monitor patient after medication
administration
remain up to date on the ever-changing obligations and standards of practice and care. If standards of care are not met, the
nurse becomes liable for negligence and malpractice (Box 3.2).
Current nursing literature remains an authoritative resource
for information on new standards of care. Provincial/territorial
nursing associations have websites that include links to specific
nurse practice acts and standards of care.
The legal–ethical dimensions of professional nursing care
are also addressed in the legislation passed to amplify the
guidelines contained in the Government of Canada Privacy Act
(1985). The Privacy Act regulates how federal government institutions collect, use, and disclose personal information. Under
these federal regulations (see page 37), the privacy of patient
information is protected, and standards are included for the
handling of electronic data about patients (PIPEDA). PIPEDA
also defines the rights and privileges of patients in order to protect privacy without diminishing access to quality health care.
The assurance of privacy—even prior to establishment of the
PIPEDA guidelines—was based on the principle of respect of
an individual’s right to determine when, to what extent, and
under what circumstances private information can be shared
or withheld from others, including family members. In addition, confidentiality must be preserved; that is, the individual
identities of patients or research study participants are not to
be linked to information they provide and cannot be publicly
divulged. PIPEDA addresses the issues of confidentiality and
privacy by prohibiting prescribers, nurses, and other health
care providers from sharing with others any patient health
43
care information, including laboratory results, diagnoses, and
prognoses, without the patient’s consent. Conflicting obligations arise when a patient wants to keep information away from
insurance companies, and matters remain complicated and
challenging in the era of improving technology and computerization of medical records. Health care facilities continue to
work diligently, however, to adhere to PIPEDA guidelines and
use special access codes to limit who can access information in
computerized documents and charts.
In summary, federal and provincial or territorial legislation,
standards of care, and nurse practice acts provide the legal
framework for safe nursing practice, including drug therapy and
medication administration. Further, as discussed in Chapter
1, the standard “Rights” of medication administration are yet
another measure for ensuring safety and adherence to laws necessary for protecting the patient. Chapter 1 also discusses other
patient rights that are part of the standards of practice of every
licensed registered nurse and every student studying the art and
science of nursing.
ETHICAL CONSIDERATIONS
Decisions in health care are seldom made independently of
other people and are made with consideration of the patient,
family, nurses, and other members of the health care team. All
members of the health care team must make a concentrated
effort to recognize and understand their own values and be considerate, nonjudgemental, and respectful of the values of others.
The use of drug therapy has evolved from just administering
whatever was prescribed to providing responsible drug therapy
for the purpose of achieving defined outcomes that improve a
patient’s quality of life based on the nursing process.
Ethical principles are useful strategies for members of the
health care team and include standards or truths on which
ethical actions are made. Some of the most useful ethical
principles in nursing and health care, specifically drug therapy, include autonomy, beneficence, nonmaleficence, justice,
fidelity, and veracity (see Legal & Ethical Principles box:
Ethical Principles in Nursing and Health Care). However,
day-to-day practice in nursing and health care poses many
potential ethical conflicts. Each situation is different and
requires compassionate and humane solutions. When
answers to ethical dilemmas remain unclear and ethical conflict occurs, then the appropriate action must be based on
ethical principles.
Ethical Nursing Considerations and Drug Therapy
Ethical nursing practice is based on basic ethical principles such
as beneficence, autonomy, justice, fidelity, veracity, and confidentiality. The CNA Code of Ethics for Registered Nurses (2017),
the Canadian Council for Practical Nurse Regulators (CCPNR)
Code of Ethics (2013), and the International Council of Nurses
(ICN) Code of Ethics for Nurses (2012) serve as frameworks
of practice for nurses and as ethical guidelines for nursing care
(see the Legal & Ethical Principles box: International Council of
Nurses Code of Ethics for Nurses).
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PART 1 Pharmacology Basics
LEGAL & ETHICAL PRINCIPLES
Ethical Principles in Nursing and Health Care (example Code of Ethics)
Element
Example
Providing safe, compassionate,
competent, and ethical care
Nurses have an ethical responsibility to provide compassionate, safe, and competent care. Nurses must always question
unsafe, incompetent practice or conditions that interfere with their ability to provide safe, compassionate, competent,
and ethical care. By building trustworthy relationships, nurses engage in compassionate care that addresses the needs
of individuals, families, and communities.
Nurses work with and provide care to persons to achieve their highest level of health and well-being.
Nurses must always acknowledge, respect, promote, and advocate for a person’s ability to be informed of all information in
order to make decisions about their health care.
Nurses support persons receiving care by maintaining their dignity and integrity through recognizing and respecting the
intrinsic worth of each person.
Nurses acknowledge the importance of privacy and confidentiality and safeguard personal, family, and community information obtained in the context of a professional relationship.
Nurses uphold principles of justice by safeguarding human rights, equity, and fairness and by promoting the public good.
Nurses are accountable for their actions and answerable for their practice. Nurses must maintain their fitness to practice.
Promoting health and well-being
Promoting and respecting informed
decision making
Honouring dignity
Maintaining privacy and
confidentiality
Promoting justice
Being accountable
Based on Canadian Nurses Association. (2017). Code of ethics for registered nurses. Ottawa, ON: Retrieved from https://www.cna-aiic.ca/-/media/
cna/page-content/pdf-en/code-of-ethics-2017-edition-secure-interactive.pdf.
LEGAL & ETHICAL PRINCIPLES
International Council of Nurses Code of Ethics for Nurses
The International Council of Nurses (ICN) first adopted The ICN Code of Ethics
for Nurses in 1953; the Code has been revised several times since then, most
recently in 2012. The 2012 revision is available in English, French, Spanish, and
German. This Code is a globally accepted guide for ethical practice in nursing,
based on social values and needs. The preamble identifies the four fundamental responsibilities of nurses—promoting health, preventing illness, restoring
health, and alleviating suffering—and points out that the need for nursing is
universal. The Code makes it clear that inherent in professional nursing practice
is respect for human rights, including the right to life, dignity, and the right to
be treated with respect. Nursing care is respectful of and unrestricted by considerations of age, colour, creed, culture, disability or illness, sexual orientation, nationality, politics, race, or social status. Nurses render services to the
individual, family, and community. The Code describes four principal elements
that provide a framework for the standards of ethical conduct it defines: nurses
and people, nurses and practice, nurses and the profession, and nurses and
co-workers. The 2012 updated code reflects the current professional emphases
on positive work environments and the use of evidence-informed practice. The
ICN Code of Ethics for Nurses serves as a guide for action based on social values
and needs and should be understood, internalized, and applied by nurses in all
aspects of their work. Nurses can obtain assistance in translating these standards into conduct by discussing the Code with co-workers and collaborating
with their national nurses’ associations in the application of ethical standards in
nursing practice, education, management, and research.
Adherence to these ethical principles and codes of ethics ensures that the
nurse is acting on behalf of the patient and with the patient’s best interests. The
professional nurse has the responsibility to provide safe nursing care to patients
regardless of the setting, person, group, community, or family involved. Although
it is not within the nurse’s realm of ethical and professional responsibility to
impose her values or standards on the patient, it is within the nurse’s realm
to provide information and to assist the patient in facing decisions regarding
health care.
The nurse also has the right to refuse to participate in any treatment or aspect
of a patient’s care that violates the nurse’s personal ethical principles. However,
this must be done without abandoning the patient, and in some facilities the
nurse may be transferred to another patient care assignment only if the transfer
is approved by the nurse manager or nurse supervisor. The nurse must always
remember, however, that the CNA Code of Ethics for Registered Nurses and
professional responsibility and accountability require the nurse to provide nonjudgemental nursing care from the start of the patient’s treatment until the time
of the patient’s discharge. If transferring to a different assignment is not an
option because of institutional policy and because of the increase in the acuteness of patients’ conditions and the high patient-to-nurse workload, then the
nurse must always act in the best interests of the patient while remaining an
objective patient advocate.
It is always the nurse’s responsibility to provide the highest quality nursing
care and practise within the professional standards of care. The CNA Code of
Ethics for Registered Nurses; The ICN Code of Ethics for Nurses; standards of
nursing practice; federal, provincial, or territorial codes; ethical principles; and
the previously mentioned legal principles and legislation are readily accessible
and provide nurses with a sound, rational framework for professional nursing
practice.
Another area of ethical consideration regarding drug therapy and the nursing
process is the use of placebos. A placebo is a drug dosage form (e.g., tablet
or capsule) without any pharmacological activity due to a lack of active ingredients. However, there may be reported therapeutic responses, and placebos
have been found to be beneficial in certain patients, such as those being treated
for anxiety. Indeed, in an online survey of 606 physicians, including psychiatrists and nonpsychiatrists, 20% prescribed placebos regularly as part of routine
clinical practice (Raz et al., 2011). Placebos are also administered frequently in
experimental studies of new drugs to evaluate and measure the pharmacological
effects of a new medicine compared with those of an inert placebo. Except in
new drug studies, however, placebo use is considered to be unethical, creating
mistrust among the nurse, the prescriber, and the patient. Many health care
agencies limit the use of placebos to research only, to avoid the possible mistrust. In Canada, there are no specific formal guidelines on the use of placebos.
If administration of a placebo is part of a research study or clinical trial, the
informed consent process must be thorough and patients must be informed of
their right to (1) leave the study at any time without any pressure or coercion to
stay, (2) leave the study without consequences to medical care, (3) receive full
and complete information about the study, and (4) be aware of all alternative
options and receive information on all treatments, including placebo therapy,
being administered in the study.
CHAPTER 3 Legal and Ethical Considerations
45
CASE STUDY
Clinical Drug Trial
A patient on the cardiac telemetry unit, Claude, has
had a serious heart condition for years and has been
through every known protocol for treatment. The
cardiologist has admitted him to a telemetry unit for
observation during a trial of a new investigational
drug. Claude exclaims, “I have high hopes for this
drug. I’ve read about it on the internet and the reports
are wonderful. I can’t wait to get better!”
1. What is the best way for the nurse to respond to
this statement?
The physician meets with Claude and the nurse to
explain the medication and how the double-blind experimental drug study will
work. The purpose of the medication and potential hazards of the therapy are
described, as well as the laboratory tests that will be performed to measure
the drug’s effectiveness. The physician then asks the nurse to have Claude
sign the consent form. When the nurse goes to get Claude’s signature, he
says, “I’ll sign it, but I really didn’t understand what that doctor told me about
the placebo.”
2. Should the nurse continue with getting the consent form signed? Explain your
answer.
3. Claude tells the nurse, “How can I make sure I have the real drug and not the
fake drug? I really want to see if it will help my situation.” What is the nurse’s
best response?
4. After a week, Claude tells the nurse, “I don’t see that this drug is helping me.
In fact, I feel worse. But I’m afraid to tell the doctor that I want to stop the
medicine. What do I do?” What is the nurse’s best response?
KEY POINTS
• Various pieces of federal legislation, as well as provincial
or territorial law, provincial or territorial practice acts, and
institutional policies, have been established to help ensure
the safety and efficacy of drug therapy and the nursing process.
• Privacy guidelines have increased awareness concerning
patient confidentiality and privacy. It is important to understand the federal, provincial, or territorial legislation as it
relates to drug therapy and the nursing process.
• The Food and Drugs Act and the Controlled Drugs and Substances Act provide nurses and other health care providers
with information on drugs that cause little to no dependence versus those associated with a high level of abuse and
dependency.
• Always obtain informed consent as needed with complete
understanding of your role and responsibilities as a patient
advocate in obtaining such consent.
• In the IND research process, adhere to the study protocol
while also acting as a patient advocate and honouring the
patient’s right to safe, quality nursing care.
• Adhere to legal guidelines, ethical principles, and the CNA
Code of Ethics for Registered Nurses so your actions are based
on a solid foundation.
• Placebo use remains controversial and if a placebo is ordered,
question the prescriber about the specific rationale for its
use.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. Ahmed is undergoing major surgery and asks the nurse
about a living will. He states, “I don’t want anybody making decisions for me. And I don’t want to prolong my life.”
Ahmed is demonstrating
a. Autonomy
b. Beneficence
c. Justice
d. Veracity
2. Jennifer is being counselled for possible participation in a
clinical trial for a new medication. After she meets with the
physician, the nurse is asked to obtain her signature on the
consent forms. The nurse knows that this “informed consent” indicates which of the following?
a. Once therapy has begun, the patient cannot withdraw
from the clinical trial.
b. The patient has been informed of all potential hazards and
benefits of the therapy.
c. The patient has received only the information that will
help to make the clinical trial a success.
d. No matter what happens, the patient will not be able to
sue the researchers for damages.
3. A new drug has been approved for use, and the drug manufacturer has made it available for sale. During the first 6
months, Health Canada receives reports of severe adverse
effects that were not discovered during the testing and considers whether to withdraw the drug. This illustrates which
phase of investigational drug studies?
a. Phase I
b. Phase II
c. Phase III
d. Phase IV
4. When discussing the laws on legal marihuana use in Canada
with a patient, which facts does the nurse consider? (Select
all that apply.)
a. Marihuana is considered a legal substance.
b. Medical marihuana is produced via Health Canada–
regulated producers.
c. The Marihuana Medical Access Program governs the use
of medical marihuana.
d. Licensed regulators are required to provide quarterly
reports upon request to provincial and territorial licensing bodies.
46
PART 1 Pharmacology Basics
e. Medical marihuana can legally be consumed in other
forms.
5. The nurse is reviewing the four clinical phases of investigational drug studies. Place the four phases in the correct order
of occurrence.
a. Studies that are voluntarily conducted by pharmaceutical
companies to obtain more information about the therapeutic and adverse effects of a drug
b. Studies that involve small numbers of volunteers who
have the disease or ailment that the drug is designed to
diagnose or treat
c. Studies that involve small numbers of healthy subjects
who do not have the disease or ailment that the drug is
intended to treat
d. Studies that involve large numbers of patients who have
the disease that the drug is intended to treat; these studies
establish the drug’s clinical effectiveness, safety, and dosage range
Critical Thinking Activities
1. During a busy shift, the nurse is called to the telephone to
speak to a family member of Sheila, who was admitted with
pneumonia. The caller states, “I’m her grandson, and I want
to know if the pneumonia she has is that contagious bug
that’s going around hospitals. Is she going to die?” Which
guidelines will the nurse use to answer the family member?
2. The nurse is assessing a newly admitted 55-year-old woman.
During the assessment, the nurse finds that the patient uses
cannabis for anxiety. What questions are appropriate regarding the patient’s use of cannabis?
3. Using the suggestions given in this chapter of your textbook,
interview someone who is not in your ethnocultural group
about cultural practices and drug therapy. Compare the person’s practices with those of your family.
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
Government of Canada. (1985). Privacy act. Retrieved from:
https://laws-lois.justice.gc.ca/eng/acts/P-21/.
Government of Canada. (2018). Cannabis for medical purposes under
the Cannabis Act: Information and improvements. Retrieved from
https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/medical-use-cannabis.html.
International Council of Nurses. (2012). The international code of ethics for nursing. Geneva, CH: Author. Retrieved from http://www.
icn.ch/who-we-are/code-of-ethics-for-nurses/.
Law, M. R., Cheng, L., Dhalla, I. A., Heard, D., & Morgan, S. G.
(2012). The effect of cost on adherence to prescription medications in Canada. Canadian Medical Association Journal, 184(3),
297–302. https://doi.org/10.1503/cmaj.111270.
Raz, A., Campbell, N., Guindi, D., et al. (2011). Placebos in clinical practice: Comparing attitudes, beliefs, and patterns of
use between academic psychiatrists and nonpsychiatrists.
Canadian Journal of Psychiatry, 56(4), 198–208. https://doi.
org/10.1177/070674371105600403.
Website
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•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
REFERENCES
Canadian Council for Practical Nurse Regulators. (2013). Code of
ethics for licensed practical nurses in Canada. Retrieved from http://
www.ccpnr.ca/wp-content/uploads/2013/09/IJLPN-CE-Final.pdf.
Canadian Nurses Association. (2015). Framework for registered nurse
prescribing in Canada. Retrieved from https://www.cna-aiic.ca/-/
media/cna/page-content/pdf-en/cna-rn-prescribing-framework_e.
pdf?la=en&hash=9FDF63DEC707BD650944783798954ADAAB1EA150.
4
Patient-Focused Considerations
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Discuss the influences of a patient’s age on the effects of
drugs and drug responses.
2. Summarize the impact of age-related physiological
changes on pharmacokinetic aspects of drug therapy.
3. Explain how these age-related changes in
pharmacokinetics influence various drug effects and drug
responses across the lifespan.
4. Provide several examples of how age affects the
absorption, distribution, metabolism, and excretion of
drugs.
5. Identify drug-related concerns during pregnancy and
lactation and provide an explanation of the physiological
basis for these concerns.
6. Calculate a drug dose for a pediatric patient using the
various formulas available.
7. Identify the importance of a body surface area nomogram
for drug calculations in pediatric patients.
8. Discuss the various ethnocultural factors that may
influence an individual’s response to medications.
9. Identify various ethnocultural phenomena affecting health
care and use of medications.
10. List the drugs more commonly associated with variations
in response that are more commonly due to ethnocultural
factors.
11. Develop a collaborative plan of care for drug therapy
and the nursing process that considers lifespan and
ethnocultural considerations.
KEY TERMS
Active transport The active (energy-requiring) movement
of a substance between different tissues via pumping
mechanisms contained within cell membranes. (p. 48)
Culture The customary beliefs, social forms, and material
traits of a racial, religious, or social group. (p. 55)
Diffusion The passive movement of a substance (e.g., a
drug) between different tissues, from areas of higher
concentration to areas of lower concentration. (Compare
with active transport.) (p. 48)
Neonate A person younger than 1 month of age; newborn
infant. (p. 49)
Nomogram A graphical tool for estimating drug dosages
using various body measurements. (p. 50)
Older adult A person who is 65 years of age or older. (Note:
Some sources consider older adults to be 50 to 55 years of
age or older.) (p. 50)
Pediatric Pertaining to a person who is 18 years of age or
younger. (Note: Some sources consider pediatric to be 12
years of age or younger.) (p. 49)
Polypharmacy The use of many different drugs concurrently
in treating a patient, often one who has several health
problems. (p. 52)
Race Descendants of a common ancestor; a tribe, family, or
people believed to belong to the same lineage. (p. 55)
OVERVIEW
Most experience with drugs and pharmacology has been
gained from the adult population. Most drug studies have
focused on the population between 13 and 65 years of age. It has
been estimated that approximately 75% of currently approved
drugs lack Health Canada approval for pediatric use and therefore lack specific dosage guidelines for neonates and children
(Rieder, 2011). Fortunately, many excellent pediatric drug dosage books are available. Most drugs are effective in younger and
older patients, but often drugs behave differently in patients at
the opposite ends of the age spectrum. It is vitally important
from the standpoint of safe and effective drug administration
to understand what these differences are and how to adjust for
them.
From the beginning to the end of life, the human body changes
in many ways. These changes have a dramatic effect on the four
phases of pharmacokinetics—drug absorption, distribution,
metabolism, and excretion. Newborns, children, and older
adults all have special needs. Drug therapy at the two ends of
the spectrum of life is more likely to result in adverse effects and
toxicity. This is especially true if certain basic principles are not
understood and followed. Fortunately, response to drug therapy
changes in a predictable manner in younger and older patients.
Knowing the effect that age has on the pharmacokinetic characteristics of drugs helps predict these changes.
47
48
PART 1 Pharmacology Basics
Drug Therapy During Pregnancy
A fetus is exposed to many of the same substances as the mother,
including any drugs that she takes—prescription, nonprescription, or illicit drugs. The first trimester of pregnancy is generally
the period of greatest danger of drug-induced developmental
defects.
Transfer of both drugs and nutrients to the fetus occurs primarily by diffusion across the placenta, although not all drugs
cross the placenta. Recall from chemistry that diffusion is a
passive process based on differences in concentration between
different tissues. Active transport requires the expenditure
of energy and often involves some sort of cell-surface protein
pump. The factors that contribute to the safety or potential
harm of drug therapy during pregnancy can be broadly broken
down into three areas: drug properties, fetal gestational age, and
maternal factors.
Drug properties that impact drug transfer to the fetus include
the drug’s chemistry, its dosage, and concurrently administered drugs. Examples of relevant chemical properties include
molecular weight, protein binding, lipid solubility, and chemical structure. Important drug dosage variables include dose and
duration of therapy.
Fetal gestational age is an important factor in determining the
potential for harmful drug effects to the fetus. The fetus is at the
greatest potential for drug-induced developmental defects during
the first trimester of pregnancy. During this period, the fetus undergoes rapid cell proliferation. Skeleton, muscles, limbs, and visceral
organs are developing at their most rapid rate. Self-treatment of
any minor illness is strongly discouraged any time during pregnancy, but particularly during the first trimester. Gestational age is
also important in determining when a drug can most easily cross
the placenta to the fetus. During the last trimester, the greatest percentage of maternally absorbed drug gets to the fetus.
Maternal factors also play a role in determining drug effects
on the fetus. Any change in the mother’s physiology can affect
the amount of drug to which the fetus may be exposed. Maternal
kidney and liver functions affect drug metabolism and excretion. Impairment in either kidney or liver function may result
in higher drug levels or prolonged drug exposure and thus
increased fetal transfer. Maternal genotype may also affect how
certain drugs are metabolized (pharmacogenetics). The lack of
certain enzyme systems may result in adverse drug effects to
the fetus when the mother is exposed to a drug that is normally
metabolized by that enzyme.
Although exposure of the fetus to drugs is most detrimental
during the first trimester, drug transfer to the fetus is more likely
during the last trimester. This is the result of enhanced blood
flow to the fetus, increased fetal surface area, and increased
amount of free drug in the mother’s circulation. There may be
some specific situations when a drug may be used in one trimester but not in another.
It is important to use drugs judiciously during pregnancy;
however, there are certain situations that require their use.
Without drug therapy, maternal conditions such as hypertension, epilepsy, diabetes, and infection could seriously endanger
both the mother and the fetus, and the potential for harm far
outweighs the risks of appropriate drug therapy.
TABLE 4.1
Pregnancy Safety Categories
Subsection Description
Pregnancy
Provides information about the use of the drug in women
who are pregnant (e.g., dose and potential risk to the
developing fetus). Information about the existence of a
pregnancy registry that collects and maintains data on
how pregnant women are affected when they use the
prescribed drug or biological product is also required.
Lactation
Provides information about the use of the drug while breastfeeding (e.g., amount of drug in breast milk and potential
effects on the child being breastfed).
Females and
Provides information about how a drug may affect pregMales of
nancy testing, contraception, and infertility as it relates to
Reproductive
the drug. This information has been included in labelling,
Potential
but there was no consistent placement for it until now.
Note: Within the pregnancy and lactation subsections will be three
subheadings: risk summary, clinical considerations, and data. These
subheadings will provide more detailed information (e.g., human and
animal data on the use of the drug, specific adverse reactions of concern for pregnant or breastfeeding women).
Source: U.S. Food & Drug Administration. (2016). Pregnancy and
lactation labeling (drugs) final rule. Retrieved from http://www.fda.gov/
Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.
In 1979, in response to the thalidomide tragedy, the U.S. Food
& Drug Administration (FDA) implemented labelling requirements with the intent of providing evidence-informed information about the use of medication in pregnancy. In 2014, the
FDA introduced a labelling rule that replaces the former product letter risk categories—A, B, C, D, and X—with three detailed
realistic subsections that describe the risks and benefits of prescription drugs and biologic medicines used by women who are
pregnant and lactating. The three main categories include: pregnancy, lactation, and females and males of reproductive potential; the rule came into effect in June of 2015. Health Canada
(2018a) recommends labelling risks for medication for both
prescription and nonprescription medication. Canadian drug
labels and monographs must include information regarding risk
during pregnancy and for breastfeeding women.
(See Health Canada [2015] Guidance Document:
Labelling of Pharmaceutical Drugs for Human Use:
https://www.canada.ca/en/health-canada/services/drugshealth-products/drug-products/applications-submissions/
guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html#a521; and Health
Canada [2018b] Notice: Guidance Document: Labelling
Requirements for Nonprescription Drugs: https://www.
canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/
guidance-documents/labelling-requirements-non-prescription-drugs/notice-aug-2018.html). The categories are described
in Table 4.1.
Drug Therapy During Breastfeeding
Breastfed infants are at potential for exposure to drugs consumed by the mother. A wide variety of drugs easily cross
CHAPTER 4 Patient-Focused Considerations
TABLE 4.2
Classification of Young Patients
49
SPECIAL POPULATIONS: CHILDREN
Age Range
Classification
Pharmacokinetic Changes in Children
Younger than 38 wks gestation
Premature or preterm infant
Younger than 1 mo
Neonate or newborn infant
1 mo to younger than 1 yr
Infant
1 yr to 12 yr
Child
13 yr to 19 yr
Adolescent
Absorption
• Gastric pH is less acidic because acid-producing cells in the stomach are
immature until approximately 1 to 2 years of age.
• Gastric emptying is slowed because of slow or irregular peristalsis, which
can result in a greater time difference between drug administration and
plasma concentration. Drug absorption may potentially be increased.
• First-pass elimination by the liver is reduced because of the immaturity of
the liver and reduced levels of microsomal enzymes.
• Reduced bile salt formation decreases bioavailability of lipophilic drugs.
• Intramuscular absorption is faster and irregular.
Note: The meaning of the term pediatric may vary with the individual
drug and clinical situation. Often the maximum age for a pediatric
patient may be identified as 16 years of age. Consult manufacturer’s
guidelines for specific dosing information.
from the mother’s circulation into the breast milk and subsequently to the breastfeeding infant. Drug properties like
those discussed in the previous section influence the exposure of infants to drugs via breastfeeding. The primary drug
characteristics that increase the likelihood of drug transfer via breastfeeding include fat solubility, low molecular
weight, nonionization, and high concentration. Some drugs
that are considered weak basics may accumulate in breast
milk.
Fortunately, breast milk is not the primary route for
maternal drug excretion. Drug levels in breast milk are usually lower than those in the maternal circulation. The actual
amount of exposure depends largely on the volume of milk
consumed. The ultimate decision as to whether a breastfeeding mother should take a drug depends on the risk–benefit
ratio. The risks of drug transfer to the infant in relation to
the benefits of continuing breastfeeding and the therapeutic
benefits to the mother must be considered on a case-by-case
basis.
Considerations for Children: Neonatal and Pediatric
Patients
Pediatric patients are defined based on age. The term neonate is used for the period between birth and 1 month of
age. An infant is between 1 and 12 months of age, a child is
between 1 and 12 years of age, and an adolescent is between
13 and 19 years of age. The age ranges that correspond to
the various terms applied to pediatric patients are shown in
Table 4.2.
Physiology and Pharmacokinetics
Pediatric pharmacotherapy focuses on the unique therapeutic
needs of neonates, infants, children, and adolescents. Patients
in these age groups offer challenges distinct from those of adult
patients. Drugs behave differently in this population; for example, medications may not be absorbed, distributed, metabolized,
or eliminated in the same manner as in adults, causing increased
or decreased efficacy or safety. As well, pediatric patients handle
drugs much differently from adult patients, based primarily on
the immaturity of vital organs. In both neonates and older pediatric patients, anatomical structures and physiological systems
and functions are still in the process of developing. The Special
Populations: Children box on this page lists those physiological
Distribution
• Total body water is 70 to 80% in full-term infants, 85% in premature newborns, and 64% in children 1 to 12 years of age, resulting in increased
distribution and dilution of water-soluble drugs in these groups.
• Fat content is lower in young patients because of greater total body water.
• Protein binding is decreased because of decreased production of protein
by the immature liver; lower protein binding can result in higher concentrations of free drugs in the body.
• More drugs enter the brain because of an immature blood–brain barrier.
Consequently, some drugs will have an enhanced effect.
Metabolism
• Levels of microsomal enzymes are decreased because the immature liver
has not yet started producing enough.
• Once liver enzymes are produced, older children may have increased
metabolism and require higher doses or more frequent administration of
medications (particularly pain medications).
• Many variables affect metabolism in premature infants, infants, and children, including the status of liver enzyme production, genetic differences,
and substances to which the mother was exposed during pregnancy. For
example, the neonatal liver is not yet developed sufficiently to be able to
metabolize a large proportion of drug substrates.
Excretion
• Glomerular filtration rate and tubular secretion and resorption are all
decreased in young patients because of kidney immaturity; drug excretion
is decreased.
• Perfusion to the kidneys may be decreased, which results in reduced kidney
function, concentrating ability, and excretion of drugs.
factors that alter the pharmacokinetic properties of drugs in
young patients.
Pharmacodynamics
Drug actions (or pharmacodynamics) are altered in young
patients, and the maturity of various organs determines how
drugs act in the body. Certain drugs may be more toxic,
whereas others may be less toxic. The sensitivity of receptor
sites may also vary with age; thus, higher or lower dosages
may be required, depending on the drug. In addition, rapidly
developing tissues may be more sensitive to certain drugs,
and therefore smaller doses may be required. Because of this
receptor sensitivity, certain drugs are generally contraindicated during the growth years. For instance, tetracycline may
permanently discolour a young person’s teeth; corticosteroids
50
PART 1 Pharmacology Basics
may suppress growth when given systemically (but not when
delivered via asthma inhalers, for example); and quinolone
antibiotics may damage cartilage.
Dosage Calculations for Pediatric Patients
Most drugs have not been sufficiently investigated to ensure
their safety and effectiveness in children. Despite this lack of
research, there are numerous excellent pediatric dosage references. Because pediatric patients (especially premature infants
and neonates) have small bodies and immature organs, they
are particularly susceptible to drug interactions, toxicity, and
unusual drug responses. Pediatric patients require different
dosage calculations than adults do. Characteristics of pediatric patients that have a significant effect on dosage calculation
include the following:
• The skin is thinner and more permeable.
• The stomach lacks acid to kill bacteria.
• The lungs have weaker mucous barriers.
• Body temperature is less well regulated and dehydration
occurs easily.
• The liver and kidneys are immature and so drug metabolism
and excretion are reduced.
Many formulas for pediatric dosage calculation have been
used throughout the years. Formulas involving age, weight, and
body surface area (BSA) are most commonly employed as the
basis for calculations.
BSA-based formulas are the most accurate of the dosage formulas and are used primarily for calculating doses
of chemotherapy and for high-risk infants such as preterm
infants. The ratio of BSA varies with the length of the
infant. For the BSA method, the nurse needs the following
information:
• Drug order with drug name, dose, route, time, and frequency
• Information regarding available dosage forms
• Pediatric patient’s height in centimetres (cm) and weight in
kilograms (kg)
• BSA nomogram for children (e.g., West nomogram shown
in Fig. 4.1]; there are other modified formulations for determining BSA available)
• Recommended adult drug dosage
The West nomogram (see Fig. 4.1) uses a child’s height and
weight to determine the child’s BSA. This information is then
inserted into the BSA formula to obtain a drug dosage for a specific pediatric patient. Online calculators that determine BSA
using the West nomogram and other applications are widely
available online.
Consider the following examples:
BSA of Child
× Adult dose = Estimated child ′s dose
BSA of Adult
Manufacturer ′s
Recommended dose Estimated
BSA of
=
Child (m2) ×
child’s dose
m2
The most commonly used method to calculate drug dosages
is the body weight method. Most drug references recommend
dosages based on milligrams per kilogram of body weight.
Weight-based dosage calculators are available online. The following information is needed to calculate the pediatric dosage:
• Drug order (as discussed previously)
• Pediatric patient’s weight in kilograms (1 kg 2.2 pounds)
• Pediatric dosage as per manufacturer or drug formulary
guidelines
• Information regarding available dosage forms
When using either of the previous methods, the nurse must do
the following to ensure the correct pediatric dose:
• Determine the pediatric patient’s weight in kilograms
• Use a current drug reference to determine the usual dosage
range per 24 hours in milligrams (mg) per kilogram (kg)
• Determine the dose parameters by multiplying the weight
by the minimum and maximum daily doses of the drug (the
safe range)
• Determine the total amount of the drug to administer per
dose and per day
• Compare the drug dosage prescribed with the calculated safe
range
• If the drug dosage raises any concerns or varies from the safe
range, contact the health care provider or prescriber immediately and do not give the drug
A common source of medication error and potential toxicity
is confusing pounds with kilograms. Unless otherwise noted,
the child’s weight is to be given in kilograms, not pounds. Take
great care to ensure that the correct weight is reported to the
prescriber. In calculating pediatric dosages, the factor of organ
maturity must always be considered, along with BSA, age, and
weight. When all of these physical developmental factors are
considered, the likelihood of safe and effective drug administration is increased. Emotional developmental considerations
must also be a part of the decision-making process in drug therapy with pediatric patients.
Considerations for Older Adult Patients
Due to the decline in organ function that occurs with advancing
age, older adult patients handle drugs physiologically differently
from adult patients. Drug therapy in older adults is more likely
to result in adverse effects and toxicity.
An older adult is defined as one who is 65 years of age or
older. The terms elderly and older adult have different meanings
in different societies, so their definitions are somewhat arbitrary. In most developed countries, these terms refer to retirement age, which often occurs around the age of 65. However,
for research purposes, subgroups of older adults, such as the
“younger old” (ages 65 to 75), the “older old” (ages 75 to 85), and
“oldest old” (ages 85+) may be identified. It is also important to
note that chronological age is not a precise marker for changes
that accompany aging. There are dramatic variations in health
status, levels of participation, and independence among older
adults of the same age.
This segment of the population is growing at a dramatic
pace (See Special Populations: Older Adults box: Percentage
CHAPTER 4 Patient-Focused Considerations
51
Fig. 4.1 West nomogram for infants and children. S.A., surface area. (Modified from data by Boyd, E., &
West, C. D. (2011). In R. M. Kliegman, B. Stanton, J. St. Geme, et al. (Eds.) Nelson textbook of pediatrics
(19th ed.). Philadelphia: Saunders.)
of Population Older than 65 Years of Age). At the beginning
of the twentieth century, older adults constituted a mere
5% of the total population in Canada. At that time, more
people died of infections than of degenerative, chronic illnesses such as heart disease, cancer, and diabetes. As medical and health care technology has advanced, so has the
ability to prolong life. This shift has resulted in a growing
population of older adults that is expected to continue for
decades. Statistics Canada (2015) estimates that, by 2030, the
older adult population will accelerate beyond previous 2013
estimations. When the youngest of the baby boomers turn
65 in 2030, the total Canadian population over the age of
65 will increase to 23.6%, and by 2063, this number could
increase to up to 27.8% (see https://www150.statcan.gc.ca/
n1/pub/91-520-x/2014001/section02-eng.htm). Older adults
aged 85 years and over make up the fastest growing age group
in Canada. Life expectancy is currently approximately 81
years. These trends are expected to continue as new disease
prevention and treatment methods are developed. However,
in contrast, compared to the overall Canadian population,
First Nations, Inuit, and Métis populations are younger and
growing at a faster rate.
52
PART 1 Pharmacology Basics
SPECIAL POPULATIONS: OLDER ADULTS
Percentage of Population Older than 65 Years of
Age
Year
Percentage Over Age 65
1900
2001
2021
2031
2061
5%
12.6%
18.5%
22.8%
25.5%
Source: Government of Canada. (2014). Government of Canada —
Action for seniors report. Retrieved from https://www.canada.ca/en/
employment-social-development/programs/seniors-action-report.html.
SPECIAL POPULATIONS: OLDER ADULTS
Alzheimer’s Disease in Canada
• Alzheimer’s disease is fatal, progressive, and degenerative, affecting
approximately half a million Canadians, and the number of people affected
is expected to increase to 937 000 by 2031 (Alzheimer Society Canada,
2018a).
• Advanced age is the most significant risk factor. Alzheimer’s disease
affects 16 000 of Canadians over the age of 65, and approximately 25 000
new cases of dementia are diagnosed each year (Alzheimer Society Canada, 2018b).
• Family history and genetics are significant risk factors. Risk increases by 10
to 40% if a first-degree relative has Alzheimer’s disease. The ApoE4 gene
is the most important genetic risk factor.
• Gender also is a significant risk factor; 65% of those with Alzheimer’s disease diagnosed over the age of 65 are women (Alzheimer Society Canada,
2018c).
• Alzheimer’s disease is characterized by the slow and initially insidious
decline of memory and functional ability along with behavioural and personality changes. Hallmark abnormalities of Alzheimer’s disease include
deposits of the protein fragment beta-amyloid (plaques) and twisted
strands of the protein tau (tangles) as well as evidence of nerve cell damage and death in the brain.
• Criteria and guidelines for diagnosing Alzheimer’s disease recommend
describing it in three stages. Studies are providing evidence that a preclinical stage, when brain degeneration occurs, may begin 10 years before
the second stage, when clinical symptoms of mild cognitive impairment
emerge. The third stage is dementia (The Lancet, 2013).
• Promising areas of research focused on early detection include biological
markers such as low amyloid-β in cerebrospinal fluid and neuroimaging
techniques. Such advances will facilitate the development of disease-modifying treatments, early diagnosis, and improve clinical care (Fraller, 2013).
• Currently, there is no pharmacological cure for Alzheimer’s disease; however, there are several medications that may improve quality of life for
those with Alzheimer’s disease.
Issues in Clinical Drug Use in Older Adults
Older adults have considerable interindividual variability in
health, disability, age-related changes, polymorbidity, and
associated polypharmacy, making generalization of prescribing recommendations difficult. At any given time, the
average older adult takes up to 10 prescription drugs as well
as over-the-counter (OTC) medications, which can increase
the risk of drug interactions. According to the Canadian
Institute for Health Information (2018), approximately 1.6
million seniors, or 1 in 4 Canadians over the age of 65, were
prescribed 10 or more drug classes in 2016. The most commonly used drug in nearly half of all older adults in Canada
is a statin for high cholesterol; also common are drugs prescribed for high blood pressure, acid reflux, and peptic ulcer
disease (CIHI, 2018). Other commonly prescribed drugs
for older adults include antihypertensives, beta blockers,
diuretics, insulin, and potassium supplements. The most frequently used drugs are analgesics, laxatives, and nonsteroidal
anti-inflammatory drugs (NSAIDs). Older adults, especially
those of certain ethnicities, may use various folk remedies
of unknown composition that are unfamiliar to their health
care providers.
Not only do older adults consume a greater proportion
of prescription and OTC medications, they commonly take
multiple medications daily. One reason for the use of multiple medications is the occurrence of more chronic diseases,
which now have even more drug options available for treatment. More than 80% of patients taking eight or more drugs
have one or more chronic illnesses. More complicated medication regimens predispose older adults to self-medication
errors, especially those with reduced visual acuity and manual
dexterity. Such sensory and motor deficits can be particularly
problematic when older adults split their own tablets. The
practice of pill splitting occurs commonly for financial reasons
because lower- and higher-strength tablets often have similar
costs. Other factors that may contribute to medication errors
in older adults include lack of adequate patient education and
understanding of their drug regimens and use of multiple prescribers and multiple pharmacies. In this age of medical specialization, patients may see several prescribers for their many
illnesses. It is therefore important for the patient to use only
one pharmacy so that monitoring for drug interactions and
duplicate therapy can occur.
Older adult patients are hospitalized frequently due to
adverse drug reactions. Many people, including older adults, use
natural health products, including herbal remedies and dietary
supplements, which can interact with prescription drugs. The
simultaneous use of multiple medications is called polypharmacy. The chance of a drug interaction is approximately 6% for
a patient receiving 2 medications. The risk increases dramatically as the number of drugs the patient is taking increases. For
a patient taking 5 medications, the chance of a drug interaction
is 50%, and for those taking 10 or more medications, the chance
is 100%.
Some drugs may be given specifically to counteract the
adverse effects of other drugs (e.g., a potassium supplement
to counteract the potassium loss caused by certain diuretic
medications). This is one example of what is known as the
prescribing cascade. Often it is difficult to distinguish adverse
drug effects from disease symptoms. Although such prescribing is sometimes appropriate, it also increases the potential for
CHAPTER 4 Patient-Focused Considerations
more adverse drug events (including drug interactions, hospitalization or prolonged hospital stays, hip fractures secondary to drug-induced falls, addiction risk, anorexia, confusion,
urinary retention, and fatigue). Recognizing polypharmacy,
and taking steps to reduce it whenever possible by decreasing the number or dosages of drugs taken, can significantly
reduce the incidence of adverse outcomes. Various types of
electronic health records, e-prescribing, computerized medical order entry, and electronic medication administration
records (eMARs), as well as clinical decision support systems
(used at the point of care to make evidence-informed decisions) have the potential to reduce inappropriate prescribing
and polypharmacy in older adults. Appropriate drug doses for
older adult patients may sometimes be one-half to two-thirds
of the standard adult dose. As a rule, dosing for older adults
should follow the advice, “Start low and go slow,” which means
to start with the lowest possible dose (often less than an average adult dose) and increase the dose slowly, based on patient
response.
Another important issue in this population is nonadherence
with prescribed medication regimens. Drug nonadherence is
reported to occur in roughly 40% of older adult patients and is
associated with increased rates of hospitalization. Nonadherence
is multifactorial and may include patient factors such as poor
understanding of the disease, lack of involvement in the treatment decision-making process, reduced ability to purchase
medication, and suboptimal medical literacy; the occurrence
of adverse effects; physician factors such as prescribing complex drug regimens and not explaining the benefits and adverse
effects of a medication effectively; and health system factors
such as an overtaxed health care system with inadequate time
engaged with patients for proper assessment and understanding
of the patients’ needs (Brown & Bussell, 2011; Holt, Rung, Leon,
et al., 2013).
Physiological Changes
Physiological changes associated with aging affect the
actions of many drugs. As the body ages, the functioning of
several organ systems slowly declines. The collective physiological changes associated with the aging process have a
major effect on the disposition and action of drugs. Table
4.3 lists some of the body systems most affected by the aging
process.
The sensitivity of older adults to many drugs requires careful
monitoring and dosage adjustment. The criteria for drug dosages in older adults must include consideration of body weight
and organ functioning, with emphasis on liver, kidney, cardiovascular, and central nervous system function (similar to the
criteria for pediatric dosages). With aging, there is a general
decrease in body weight.
Changes in drug molecule receptors in the body can make a
patient more or less sensitive to certain medications. For example, older adults commonly have increased sensitivity to central
nervous system depressant medications (e.g., anxiolytics, tricyclic antidepressants) because of reduced integrity of the blood–
brain barrier.
TABLE 4.3
Adults
53
Physiological Changes in Older
System
Physiological Change
Cardiovascular
↓ Cardiac output = ↓ absorption and distribution
↓ Blood flow = ↓ absorption and distribution
Gastrointestinal
↑ pH (alkaline gastric secretions) = altered absorption
↓ Peristalsis = delayed gastric emptying
Liver
↓ Enzyme production = ↓ metabolism
↓ Blood flow = ↓ metabolism
Kidney
↓ Blood flow = ↓ excretion
↓ Function = ↓ excretion
↓ Glomerular filtration rate = ↓ excretion
The most important organs from the standpoint of the
breakdown and elimination of drugs are the liver and the
kidneys. Measurement of kidney function is an essential element of care for older adults because it may evaluate effectiveness of drug therapies and allow for drug adjustments to
prevent toxicity. Canadian guidelines to assess deteriorating kidney function and to stage kidney disease are based
on the estimated glomerular filtration rate (eGFR) and the
presence of albuminuria. Albuminuria is defined as a urine
albumin-to-creatinine ratio greater than 2.0 mg/mmoL for
men and greater than 2.8 mg/mmoL for women. Screening
of the urine creatinine/albumin level should be incorporated into routine assessments for all older adults. The serum
creatinine level in older adults may be lower because of the
decline of muscle mass (creatinine is a by-product of muscle
metabolism).
Liver function is assessed by testing the blood for liver
enzymes such as aspartate aminotransferase (AST) and alanine
aminotransferase (ALT). These laboratory values can help in
assessing the ability to metabolize and eliminate medications
and can aid in anticipating the risk of toxicity, drug accumulation, or both. Laboratory assessments need to be conducted
at least annually, both for preventive health monitoring and
for screening for possible toxic effects of drug therapy. Such
assessments may be indicated more frequently (e.g., every 1,
3, or 6 months) in those patients requiring higher-risk drug
regimens.
Pharmacokinetics
The pharmacokinetic phases of absorption, distribution, metabolism, and excretion (see Chapter 2) may be different in older
adults from those in younger adults. Awareness of these differences helps the nurse ensure appropriate administration of
drugs and monitoring of older adults. The Special Populations:
Older Adults box: Pharmacokinetic Changes lists the four pharmacokinetic phases and summarizes how they are altered by the
aging process.
Absorption. Absorption in older adults can be altered by
many mechanisms. Advancing age results in reduced absorption
of both dietary nutrients and drugs. Several physiological
54
PART 1 Pharmacology Basics
SPECIAL POPULATIONS: OLDER ADULTS
Pharmacokinetic Changes
Absorption
• Gastric pH is less acidic because of a gradual reduction in the production of
hydrochloric acid in the stomach.
• Gastric emptying is slowed because of a decline in smooth muscle tone and
motor activity.
• Movement throughout the gastrointestinal tract is slower because of
decreased muscle tone and motor activity.
• Blood flow to the gastrointestinal tract is reduced by 40 to 50% because of
decreased cardiac output and decreased perfusion.
• The absorptive surface area is decreased because the aging process blunts
and flattens villi.
Distribution
• In adults 40 to 60 years of age, total body water is 55% in males and 47%
in females; in those over 60 years of age, total body water is 52% in males
and 46% in females.
• Fat content is increased because of decreased lean body mass.
• Protein (albumin) binding sites are reduced because of decreased production of proteins by the aging liver and reduced protein intake.
Metabolism
• The levels of microsomal enzymes are decreased because the capacity of
the aging liver to produce them is reduced.
• Liver blood flow is reduced by approximately 1.5% per year after 25 years
of age, which decreases liver metabolism.
Excretion
• Glomerular filtration rate is decreased by 40 to 50%, primarily because of
decreased blood flow.
• The number of intact nephrons is decreased.
changes account for this reduction in absorption. Older adult
patients have a gradual reduction in the ability of the stomach to
produce hydrochloric acid, which results in a decrease in gastric
acidity and may alter the absorption of some drugs. In addition,
the combination of decreased cardiac output and advancing
atherosclerosis results in a general reduction in the flow of blood to
major organs, including the stomach. By 65 years of age, there is an
approximately 50% reduction in blood flow to the gastrointestinal
tract. Absorption, whether of nutrient or drug, is dependent on
good blood supply to the stomach and intestines. The absorptive
surface area of an older adult person’s gastrointestinal tract is
often reduced, thus decreasing drug absorption.
Gastrointestinal motility is important for moving substances
out of the stomach and through the gastrointestinal tract.
Muscle tone and motor activity in the gastrointestinal tract are
reduced in older adults. Often, this results in constipation, for
which older adults frequently take laxatives. The use of laxatives may accelerate gastrointestinal motility enough to actually
reduce the absorption of drugs.
Distribution. The distribution of medications throughout the
body is also different in older adults. There seems to be a gradual
reduction in the total body water content with aging. Therefore,
the concentrations of highly water-soluble (hydrophilic) drugs
may be higher in older adults because they have less body water
in which the drugs can be diluted. The composition of the body
also changes with aging, with a decrease in lean muscle mass
and an increase in body fat. In both men and women, there is
an approximately 20% reduction in muscle mass between the
ages of 25 and 65 years and a corresponding 20% increase in
body fat. Fat-soluble (or lipophilic) drugs, such as hypnotics
and sedatives, are distributed primarily to fatty tissues, which
may result in prolonged drug actions or toxicity.
Older adult patients may have reduced protein concentrations, due in part to reduced liver function. Reduced dietary
intake or poor gastrointestinal protein absorption can cause
nutritional deficiencies and reduced blood protein levels.
Regardless of the cause, the result is a reduced number of protein-binding sites for highly protein-bound drugs. This change
results in higher levels of unbound (active) drug in the blood.
Remember that only drugs that are not bound to proteins are
active. Therefore, the effects of highly protein-bound drugs may
be enhanced if their dosages are not adjusted to accommodate
any reduced serum albumin concentrations. Some highly protein-bound drugs are warfarin and phenytoin.
Metabolism. Metabolism declines with advancing age. The
transformation of active drugs into inactive metabolites is
performed primarily by the liver. The liver loses mass with age
and slowly loses its ability to metabolize drugs effectively due to
reduced production of microsomal (cytochrome P450) enzymes.
There is also a reduction in blood flow to the liver because of
reduced cardiac output and atherosclerosis. A reduction in the
hepatic blood flow of approximately 1.5% per year occurs after 25
years of age. All of these factors contribute to prolonging the halflife of many drugs (e.g., warfarin), which can potentially result in
drug accumulation if serum drug levels are not closely monitored.
Excretion. Kidney function declines in roughly two-thirds of
older adults. A reduction in the glomerular filtration rate of 40
to 50%, combined with a reduction in cardiac output leading to
reduced kidney perfusion, can result in delayed drug excretion
and therefore drug accumulation. This is especially true for drugs
with a low therapeutic index, such as digoxin. Kidney function
needs to be monitored frequently. Appropriate dose and interval
adjustments may be determined on the basis of results of kidney
and liver function studies as well as the presence of therapeutic
levels of the drug in the serum. If a decrease in kidney and liver
function is known, the dosage is usually adjusted by the prescriber
so that drug accumulation and toxicity may be minimized.
Problematic Medications for Older Adults
Certain classes of drugs are more likely to cause problems in
older adult patients because of many of the physiological alterations and pharmacokinetic changes already discussed. Table 4.4
lists some of the more common medications that are problematic.
Some drugs to be avoided in older adults have been identified by
various professional organizations such as the Institute for Safe
Medication Practices Canada (2014), as well as by various other
authoritative sources. Since the 1990s, an effective tool, the Beers
Criteria, has been used to identify drugs that may be inappropriately prescribed, be inadequate, or cause adverse drug reactions
in older adults (see the Evidence in Practice box on page 55). The
Beers Criteria are useful and help determine risk-associated situations for older adults and specific drugs that may be problematic.
CHAPTER 4 Patient-Focused Considerations
EVIDENCE IN PRACTICE
Update on Application of the Beers Criteria for
Prevention of Adverse Drug Events in Older
Adults
Review
In 1991, a panel of experts led by Mark H. Beers, MD, identified a list of
“potentially inappropriate medications” (PIMs) for use in individuals 65 years
of age and older. These criteria were intended for use with nursing home residents and then were expanded and revised to include all settings of geriatric
care. The specific aim of the project was to predict adverse drug reactions
(ADRs) in this age group. The Beers Criteria were updated in 1997 and 2002
and provided a listing of drugs and drug classes to be avoided in older adults.
The criteria also identified disease states considered to be contraindications
for some drugs. In 2005, research was conducted to confirm the relationship
between PIM prescribing, as defined by Beers Criteria, and the occurrence of
ADRs in older adult patients treated at outpatient clinics. In 2012, a list of
medications was identified and classified into three categories: (1) potentially
inappropriate medications and classes to avoid in older adults, (2) potentially
inappropriate medications and classes to avoid in older adults with certain
diseases and syndromes, and (3) medications to be used with caution in older
adults. In 2015, the Beers Criteria expanded the 2012 list with several drugs
removed from the list and with some additions.
Type of Evidence
The 2015 Beers Criteria uses a more comprehensive, systematic review and
grading of evidence than the previous 2012 updates did. The quality of the
criteria continued to include (1) application of an evidence-informed approach,
(2) support of the American Geriatrics Society (AGS) in conjunction with an
interdisciplinary panel of 13 experts in geriatric care and pharmacotherapy,
(3) use of a time-tested method for developing care guidelines while using
the Institute of Medicine’s standards for evidence/transparency as an important benchmark, and (4) an extensive review of more than 6 700 high-quality
research studies and clinical trials about prescription medications for this age
group.
Results of the Study
Consistent with the 2012 AGS Beers Criteria, the 2015 criteria support clinical
judgement. They include 40 potentially problematic medications or classes of
medications. In addition, the 2015 Beers Criteria include: (1) separate guidance
on avoiding 13 drug–drug combinations known to cause harm; (2) a specific list
of 20 problematic medications to avoid or doses that need to be adjusted in
older adults based on the patient’s kidney function; and (3) three new medications and two new “classes” of medications added to the list (e.g., proton
pump inhibitors). New in 2015 are companion guides to assist the health care
provider in using the guidelines as well as potential alternative suggestions to
the use of high-risk medications in the older adult.
Link of Evidence to Nursing Practice
These criteria update drugs to avoid and use with caution in older adults. In
addition, they increase awareness of inappropriate medication use in this age
group and may also be integrated into electronic health records. With the
support of the AGS, the criteria will continue to develop over time and will
continue to help improve the health of older adults. The criteria should be used
as a starting point from which to develop a comprehensive process to improve
medication appropriateness and safety.
Source: The American Geriatrics Society Beers Criteria Update Expert
Panel. (2015). American Geriatrics Society updated Beers Criteria
for potentially inappropriate medication use in older adults. Journal
of the American Geriatrics Society, 63(11), 2227–2246. https://doi.
org/10.1111/jgs.13702
55
Ethnocultural Considerations
Canada is a multiculturally diverse nation as evidenced by its
constant and rapidly changing demographics, owing to persistent low fertility, strong immigration, and the number of
descendants. Prior to the 1970s, 78.3% of immigration to Canada
came from European countries (e.g., the United Kingdom, Italy,
Germany, and the Netherlands). The influx of European-born
immigrants has declined steadily.
At the time of the 2016 census, approximately 21.9% of the
Canadian population had reported that they had been or were a
landed immigrant or permanent resident. This is an important
statistic because it is close to the 1921 census reported 22.3%,
which was the highest since confederation (Statistics Canada,
2017). Recent immigrants to Canada, between 2011 and 2016,
totaled 1 212 075, representing 3.5% of the Canadian population in 2016. It is estimated that one in five Canadians were born
outside of Canada, with that proportion projected to increase
up to 24.5%–30.0% by 2036. Asia and the Middle East (61.8%)
remain the primary source of recent immigrants, followed by
Africa (13.4%), with the remainder of immigrants being of
European decent (Statistics Canada, 2017).
The Indigenous population is growing faster than the rest of
the Canadian population, largely due to a younger population
and high fertility. According to Statistics Canada (2018) there
were 1 673 785 Indigenous people living in Canada in 2016,
a 42.5% increase since 2006. Between 2006 and 2016 the First
Nations population (including those registered or treaty members under the Indian act as well as those who are not) grew by
39.3% reaching 977 230 members, the Métis population grew by
51.2% to 587 545 members (the largest increase over ten years),
and the Inuit population grew by 29.1% reaching 65 025 members. It is anticipated the Indigenous population will grow to
over 2.5 million members within the next two decades.
The Indigenous population of Canada has endured many
years of colonization that have deeply impacted this culture,
robbing them of traditions including language, relationships
with land and community, as well as traditional healing practices. In 2015, the final Truth and Reconciliation Commission
(TRC) report was released (TRC, 2015). The TRC was formed in
response to the largest class action lawsuit in Canada, launched
on behalf of Indian Residential School survivors. The final TRC
report contained over 6 200 statements from some of the 80
000 Indian Residential School survivors. Stories of separation
from family and community, sexual abuse, death from illnesses
including TB and influenza, inferior living conditions, starvation, physical punishment, forced labour, together with loss of
language, family relationships, healing traditions, and cultural
identity, were recorded.
Such ethnocultural demographic shifts and changes significantly impact Canada’s health care system and the delivery of
care. The field of ethnopharmacology provides an expanding
body of knowledge for understanding the specific impact of cultural factors on patient drug response. It is hampered, however,
by the lack of clarity in terms such as race, ethnicity, and culture.
Race is based primarily upon genetically imparted physiognomical features, among which skin colour is a dominant,
56
PART 1 Pharmacology Basics
TABLE 4.4
Medications and Conditions Requiring Special Considerations for Older Adults
Medication
Common Complications
Analgesics
Opioids
Confusion, constipation, urinary retention, nausea, vomiting, respiratory depression, falls
Nonsteroidal anti-inflammatory drugs (NSAIDs)
Edema, nausea, gastric ulceration, bleeding, kidney toxicity
Anticholinergics and antihistamines
Blurred vision, dry mouth, constipation, confusion and sedation, urinary retention, tachycardia
Anticoagulants (heparin sodium, warfarin sodium)
Major and minor bleeding episodes, many drug interactions, dietary interactions
Antidepressants
Sedation and strong anticholinergic adverse effects (see above)
Antihypertensives
Nausea, orthostatic hypotension, diarrhea, bradycardia, heart failure, impotence
Cardiac glycosides (e.g., digoxin)
Visual disorders, nausea, diarrhea, dysrhythmias, hallucinations, decreased appetite, weight loss
CNS depressants (muscle relaxants, opioids)
Sedation, weakness, dry mouth, confusion, urinary retention, ataxia
Sedatives and hypnotics
Confusion, daytime sedation, ataxia, lethargy, increased risk of falls
Thiazide diuretics
Electrolyte imbalance, rashes, fatigue, leg cramps, dehydration
Condition
Drugs Requiring Special Caution and Monitoring
Bladder flow obstruction
Anticholinergics, antihistamines, decongestants, antidepressants
Clotting disorders
NSAIDs, aspirin, antiplatelet drugs
Chronic constipation
Calcium channel blockers, tricyclic antidepressants, anticholinergics
Chronic obstructive pulmonary disease
Long-acting sedatives and hypnotics, narcotics, beta blockers
Clotting disorders
NSAIDs, aspirin, antiplatelet drugs
Heart failure and hypertension
Sodium bicarbonate, decongestants, amphetamines, OTC cold products
Insomnia
Decongestants, bronchodilators, monoamine oxidase inhibitors
Parkinson’s disease
Antipsychotics, phenothiazines
Syncope and falls
Sedatives, hypnotics, narcotics, central nervous system depressants, muscle relaxants, antidepressants, antihypertensives
but not the sole, attribute. Nevertheless, it is possible for a person to be of mixed races, some of which, such as the mestizo
of Latin America, have become recognized as evolved races.
Furthermore, terminology may be ambiguous. Scholars may
prefer to use the term Caucasian rather than White, but the former may not be well understood by many respondents. Other
terminology evolves over time, such as the evolution in the
United States of African-American from Black and earlier from
negro.
The term First Nations originated in the 1970s to replace the
offensive terminology, Indian. In Canada, the term Indigenous
includes Inuit, First Nations, and Métis. The terms Indigenous
and First Nations are not interchangeable. The Inuit, meaning
people in Inuktitut, the Inuit language, are a generally homogeneous Indigenous people who live in Nunavut, the Northwest
Territories, Northern Quebec and Northern Labrador. The Inuit
population forms about 5% of all Indigenous people in Canada.
Métis are a distinct Indigenous group, with mixed ancestry
as a result of intermarriage between Indigenous women and
European men. Métis culture draws on a blend of diverse cultural origins and is unique because of this. Métis people make
up approximately 30% of the total Indigenous population. About
68% live in urban areas, with less than 3% living on reserves. First
Nations people, who make up approximately 65% of Indigenous
people in Canada, belong to over 50 distinct cultural groups or
band associations such as Cree, Mi’kmaq, or Dene. Forty-seven
percent of First Nations people live on reserves (Raphael, 2009).
It is impossible to know a patient’s genotype by either physical appearance or health care history. Ethnocultural assessment needs to be part of the assessment phase of the nursing
process. Acknowledgment and acceptance of the influences
of a patient’s cultural beliefs, values, and customs is necessary
to promote optimal health and wellness. Some practices are
discussed in the Ethnocultural Implications box on page 57.
It is important to emphasize that not every patient from the
same country shares the same culture. Many countries encompass those of diverse ethnicities, languages, and religions.
Even when a country is relatively homogeneous in terms of
ethnicity, socioeconomic, political, urban/rural, or regional
differences may result in significant diversity, affecting every
aspect of health. For this reason, each patient must be individually assessed regarding traditional beliefs and practices. Such
assessment requires development of skills in intercultural
communication. “Recipe book” approaches to assessment
of patients from certain countries or of certain religions are
not appropriate and pose risks to quality and safety of care.
Religion also has important implications for both health and
health care provision. Many lifestyle choices (e.g., diet, use of
alcohol and tobacco) are affected by religious belief. Beliefs
regarding female modesty, death and dying, reproductive
health, hygiene, use of blood products, and other issues have
important implications for many areas of health care provision. The increasing religious diversity of Canada strengthens
the imperative for health organizations to develop responsive
CHAPTER 4 Patient-Focused Considerations
practice. It is important for health care providers to be aware
of key areas affected by religious belief and practice in order to
provide culturally responsive care. There is great diversity, not
only within each of the world’s religions, but also in individual
faith and commitment to practice.
Ethnocultural Influences and Genetics on Drug Response
The concept of polymorphism is critical to an understanding of how the same drug may result in different responses
in different individuals. For example, why might a patient
57
of Chinese origin require lower dosages of an antianxiety
drug than a patient who is White? Why might a patient
who is Black respond differently to antihypertensives from
a patient who is White? Drug polymorphism refers to the
effect of a patient’s age, gender, size, body composition, and
other characteristics on the pharmacokinetics of specific
drugs. Factors contributing to drug polymorphism may
be categorized into environmental factors (e.g., diet and
nutritional status), cultural factors, and genetic (inherited)
factors.
ETHNOCULTURAL CONSIDERATIONS
A Brief Review of Common Practices Among Canada’s Major Cultural Groups
Cultural Group
Some Examples of Health Beliefs
and Alternative Healers
Asian
May believe in traditional medicine; hot and
cold foods; herbs/teas/soups; use of acupuncturist, acupressurist, and herbalist
Black people of
African descent
May practise folk medicine; employ
“root doctors” as healers; spiritualist
May use herbs, oils, and roots
Indigenous
May believe in harmony with nature and ill
spirits causing disease
May use the medicine wheel and herbs
such as:
Tobacco: wild tobacco is usually not smoked
except in pipe ceremonies and is used to
give thanks after a successful harvest or
gathering/hunt.
Sweetgrass: used for smudging (cleansing)
ceremonies. Not ingested as is poisonous.
Cedar: is ceremonial and medicinal in both red
and white form
Sage: is a traditional medicine and is used as
part of smudging ceremonies.
May use traditional healers
Smudge ceremonies, healing circles, and sweat
lodge ceremonies as common healing rituals
Verbal and Nonverbal
Communication; Touch/
Time
High respect of others,
especially of individuals
in positions of authority
Not usually comfortable with
custom of shaking hands
with those of opposite sex
Present-oriented
Asking personal questions of
someone met for the first
time seen as intrusive and
not proper
Direct eye contact seen as rude
Present-oriented
Speak in low tone of voice
Light touch of a person’s hand
is preferred versus a firm
handshake as a greeting
Present-oriented
Family
Biological Variations
Have close extended
family ties; family
needs more important
than individual needs
Many drug interactions,
lactose intolerance,
thalassemia
Have close extended
family ties
Women play important
key role in making
health care decisions
Keloid formation, sickle
cell anemia, lactose
intolerance
Have close extended
family ties; emphasis
on family
Lactose intolerance, cleft
uvula problems
Note: Each patient is unique and has his or her own cultural attitudes, beliefs, values, customs, and norms and specific health practices that may
or may not reflect some of the above examples.
58
PART 1 Pharmacology Basics
Medication response depends greatly on the level of the
patient’s adherence with the therapy regimen. Yet adherence
may vary depending on the patient’s cultural beliefs, experiences with medications, personal expectations, family expectations and influence, and level of education. Adherence is not
the only factor, however. Prescribers must also be aware that
some patients use alternative natural health remedies that can
inhibit or accelerate drug metabolism and therefore alter a
drug’s response.
Environmental and economic factors (e.g., diet) can contribute to drug response. For example, a diet high in fat has been
documented to increase the absorption of the drug griseofulvin
(an antifungal drug). Malnutrition with deficiencies in protein,
vitamins, and minerals may modify the functioning of metabolic enzymes, which may alter the body’s ability to absorb or
eliminate a medication.
Historically, most clinical drug trials were conducted using
White men, often university students, as research subjects.
However, there are data that demonstrate the impact of genetic
factors on drug pharmacokinetics and drug pharmacodynamics
or drug response (see Chapter 5). Some individuals of European
and African descent are known to be slow acetylators. This means
that their bodies attach acetyl groups to drug molecules at a relatively slow rate, which results in elevated drug concentrations.
This situation may warrant lower drug dosages. A classic example of a drug whose metabolism is affected by this characteristic
is the antituberculosis drug isoniazid. In contrast, some patients
of Japanese and Inuit descent are more rapid acetylators and
metabolize drugs more quickly, which predisposes them to subtherapeutic drug concentrations and may require higher drug
dosages.
Levels of the cytochrome P450 enzymes (see Chapter 2)
are also known to vary between ethnic groups. This variation has effects on the ability to metabolize many drugs.
Most psychotropic drugs (see Chapter 17) are metabolized in the liver in a two-phase process. Cytochrome P450
enzymes often control Phase I of the hepatic metabolism
of both antidepressants and antipsychotic drugs. This can
affect plasma drug levels, and therefore the intensity of
drug response, at different doses. Groups of Asian patients
have been shown to be “poor metabolizers” of these drugs
and often require lower dosages to achieve desired therapeutic effects. In contrast, White patients are more likely to
be classified as “ultrarapid metabolizers” and may require
higher drug dosages.
Variations are also reported between ethnic groups in the
occurrence of adverse effects. For example, patients of African
descent taking lithium may need to be monitored more closely
than others for symptoms of drug toxicity, because serum drug
levels may be higher than in White patients given the same
dosage. Likewise, patients of Japanese and Taiwanese descent
may require lower dosages of lithium. For the treatment of
hypertension, thiazide diuretics appear to be more effective in
Black people of African descent than in White people. Several
additional examples of racial and ethnic differences in drug
response are outlined in the Ethnocultural Implications box
below.
ETHNOCULTURAL CONSIDERATIONS
Examples of Varying Responses of Different
Ethnocultural Groups to Major Drug Classes
Racial or
Drug
Ethnic Group Classification Response
Black of African
Descent
Asian
Antihypertensive
drugs
Black patients of African
descent respond better to
diuretics than to beta blockers
and angiotensin-converting
enzyme inhibitors; they respond
less effectively to beta blockers
and respond best to calcium
channel blockers, especially
diltiazem. They also respond less
effectively to single-drug therapy.
Antipsychotic and Asian patients require lower doses of
antianxiety
certain drugs such as haloperidol
drugs
and statins and also respond
better to lower dosages of
antidepressants. Chinese
patients require lower dosages of
antipsychotics. Japanese patients
require lower dosages of antimania
drugs.
Note: The comparison group for all responses is patients who are
White.
Individuals throughout the world share common views and
beliefs regarding health practices and medication use. However,
there are also specific ethnocultural influences, beliefs, and
practices. Awareness of ethnocultural differences is critical
for the care of patients because of the constantly changing
Canadian demographic. As a result of these changes, attending
to each patient’s cultural background helps to ensure safe and
high-quality nursing care, including medication administration.
For example, some Black people of African descent have
health beliefs and practices that include an emphasis on proper
diet and rest; the use of herbal teas, laxatives, and protective
bracelets; and the use of folk medicine, prayer, and the “laying
on of hands.” Reliance on various home remedies can also be an
important component of their health practices. Some patients
of Asian descent, especially Chinese patients, believe in the concepts of yin and yang. Yin and yang are opposing forces that lead
to illness or health, depending on which force is dominant in the
individual and whether the forces are balanced. Balance produces healthy states. Other common health practices of patients
of Asian descent include use of acupuncture, herbal remedies,
and heat. All such beliefs and practices need to be considered—
especially when patients values their use more highly than the
use of medications. Many of these beliefs are strongly grounded
in religion. The Asian and Pacific Island racial/ethnic group also
includes people who are Thai, Vietnamese, Filipino, Korean,
and Japanese, among others.
Indigenous peoples in Canada live in diverse geographical areas. They maintain a diverse variety of rituals, symbols,
and practices, which may vary by region. Some may follow
traditional religious practices exclusively or follow a mix of
CHAPTER 4 Patient-Focused Considerations
Fig. 4.2 Indigenous Medicine Wheel. Medicine wheels embody the
concepts of direction and alignment and emphasize physical, emotional, mental, and spiritual truths. (Beaulieu, K. J. (2019). The seven
lessons of the medicine wheel. Sky Magazine. Retrieved from https://
saymag.com/the-seven-lessons-of-the-medicine-wheel/)
Christian and traditional practices, while others may choose
Indigenous practices. Their spirituality is deeply connected
to the land, including animals and plants, and life is seen as
interconnected. Traditional medicines and practices remain
an important part of the lives of Inuit, Métis and First Nations
people in Canada. Some First Nations people follow the medicine wheel (see Fig. 4.2). The medicine wheel has distinct
parts in honour of the number 4 (a number sacred to the
First Nations people), which includes 4 directions, 4 seasons,
and the 4 aspects of health (physical, emotional, intellectual,
and spiritual). These aspects are connected to Mother Earth.
Medicine wheels may include the colours red, black, white,
and red, as well as white, yellow, red, and green. In addition,
the medicine wheel may also include different animals, such
as the wolf, eagle, buffalo, or grizzly bear. Indigenous people
believe in preserving harmony with nature or keeping a balance
between the four aspects of the medicine wheel. When one area
is not functioning well, the other three areas are affected. Illness
results from a neglected or oppressed spirit or an imbalance.
Many use a traditional Indigenous healer or sacred medicines.
Medicine is distinguished from healing, which goes beyond
mere treatment of sickness. Traditional healing includes a wide
range of activities, from physical cures using herbal medicines
(such as tobacco, sage, sweetgrass, and cedar [see Ethnocultural
Implications]) and other remedies to the promotion of psychological and spiritual well-being using ceremony, counselling,
and the accumulated wisdom of elders (Beaulieu, 2019). The
drum is considered a symbol of the living relationship between
Indigenous people and the land. The traditional healer for this
culture is not only the medicine man or woman but may also
include a spiritualist and herbalist, among others. Healing
occurs through a variety of methods, including the sweat lodge,
healing lodges and circles, and the continuous journey toward
Bimaadiziiwin, or “the good life.” “Smudging” is a common
ceremony used to cleanse the body spiritually and physically.
An herb such as sage or sweetgrass is burned and the smoke is
rubbed or brushed over the body.
Ayurveda and Unani, traditional healing methods commonly
practised by South Asians, emphasize a balance between a person’s behaviour, lifestyle, environment, and mind. For example,
South Asians believe that the body’s digestive forces maintain
59
the bodily humours, and an imbalance in bodily humours leads
to physical and psychological illnesses. Muslims believe that ill
health occurs due to the will of Allah. It is important to remember that these beliefs vary from patient to patient; therefore,
consult with the patient rather than assume that the patient
holds certain beliefs because of belonging to a certain ethnic
group.
Barriers to adequate health care for the ethnoculturally
diverse Canadian patient population include language, poverty, access, pride, and beliefs regarding medical practices.
Medications may have a different meaning to different cultures,
as would any form of medical treatment. Therefore, before any
medication is administered, complete a thorough ethnocultural
assessment. This assessment includes questions in regard to the
following:
• Languages spoken, written, and understood; need for an
interpreter
• Health beliefs and practices
• Past uses of medicine
• Use of herbal treatments, folk remedies, home remedies, or
natural health products
• Use of over-the-counter (OTC) drugs
• Usual responses to illness
• Responsiveness to medical treatment
• Religious practices and beliefs (e.g., many Christian Scientists believe in taking no medications at all)
• Support from the patient’s ethnocultural community that
may provide resources or assistance as needed, such as religious connections, leaders, family members, or friends
• Dietary habits
Ethnocultural Nursing Considerations and Drug Therapy
It is important to be knowledgeable about drugs that may
elicit varied responses in culturally diverse patients or those
from different racial or ethnic groups. Varied responses
may include differences in therapeutic dosages and adverse
effects, so that some patients may have therapeutic responses
at lower dosages than are typically recommended. For example, in patients of Asian descent who take traditional antipsychotics, symptoms may be managed effectively at lower
dosages than the usual recommended dosage range. Also,
patients of Chinese descent may require lower doses of
antidepressants.
Another aspect of cultural care as it relates to drug therapy
is the recognition that patterns of communication may differ
based on a patient’s race or ethnicity. Communication includes
the use of language, tone, and volume of the voice, as well as
spatial distancing, touch, eye contact, greetings, and naming
format. It is important to assess and apply these aspects of cultural and racial or ethnic variations to patient care and to drug
therapy and the nursing process. Precise instructions must be
included in patient education about medication(s) and how
to best and safely take them. Avoiding the use of contractions such as can’t, won’t, and don’t is important with patients
who speak other languages to prevent confusion. Instead, use
of cannot, will not, and do not is recommended to improve
understanding.
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PART 1 Pharmacology Basics
NURSING PROCESS
ASSESSMENT
Pediatric Considerations
Before any medication is administered to a pediatric patient,
obtain a thorough health history and medication history with
assistance from the parent, caregiver, or legal guardian. The following are areas to be included:
• Age
• Age-related concerns about organ functioning
• Allergies to drugs and food
• Baseline values for vital signs
• Physical assessment findings
• Height in centimetres and feet/inches
• Weight in kilograms and pounds
• Medical and medication history (including adverse drug
reactions); current medication and related dosage forms
and routes, and the patient’s tolerance of the forms and
routes
• Use of prescription and OTC medications in the home setting
• Level of growth and development and related developmental
tasks
• Motor and cognitive responses and their age-appropriateness
• Age-related fears
• State of anxiety of the patient or family members or caregiver
• Usual method of medication administration, such as use of a
calibrated spoon or needleless syringe
• Usual response to medications
• Resources available to the patient and family
The prescriber will determine the medication to be delivered. However, the nurse is responsible for detecting any errors
in calculation of dosage, as well as for preparing the medication
and administering the drug. The nurse needs to be aware that
pediatric dosages are often less than 1 mL and require accurate
medication dosage calculations that are checked several times.
The Ten Rights of medication administration must be followed,
of which correct dose is one right. In addition to an assessment
of the patient, an assessment of the drug-related information
is needed, focusing specifically on the drug’s purpose, dosage
ranges, routes of administration, cautions, and contraindications. Children are more sensitive than adults to medications
because of their weight, height, physical condition, immature
systems, and metabolism. Older children’s body surface areas
and weights are still lower than those of adults, so extreme
caution is continually needed when giving them medications.
Immature organ and system development will influence pharmacokinetics and thus affect the way pediatric patients respond
to drugs. Organ function may be determined through laboratory testing. The following studies may be ordered by the prescriber before beginning drug therapy as well as during and
after drug therapy: liver and kidney function studies, red blood
cell and white blood cell counts, and measurement of hemoglobin levels, hematocrit, and protein levels.
Older Adult Considerations
Assessment data to be gathered in older adults may include the
following:
• Age
• Past and present medical history
• Allergies to drugs and food
• Dietary habits
• History of smoking and use of alcohol with notation of
amount, frequency, and years of use
• Sensory, visual, hearing, cognitive, and motor-skill deficits
• Laboratory testing results, especially those that assess kidney
and liver function
• List of all health-related care providers, including physicians;
dentists; optometrists and ophthalmologists; podiatrists;
alternative medicine health care practitioners, such as osteopathic physicians; chiropractors; and nurse practitioners
• Listing of medications, past and present, including prescription drugs, OTC medications, and natural health products
• Existence of polypharmacy (the use of more than five medications)
• Self-medication practices
• Risk situations resulting from drug therapy as identified
by the Beers Criteria (see Evidence in Practice box on
page 55)
The patient’s insight into his or her own medical problems
is a beneficial piece of information in developing a plan of care.
It is also important for the nurse to realize that although older
adults may be able to provide the required information themselves, many may be confused or poorly informed about their
medications or health condition. In such cases, consult with
a more reliable historian, such as a significant other, family
member, or caregiver. Older adults may also have sensory deficits that require the nurse to speak slowly, loudly, and clearly,
while facing the patient. Currently in Canada, drug information systems are being used in about 50% of Canada’s emergency rooms and 3% of community pharmacies, resulting in
safer use of medications and fewer adverse drug events. Access
to electronic health care records for older adults is a significant
step to improving the availability of information, quickly, as
well as the quality of and access to health care (Canada Health
Infoway, 2013).
One way to collect data about the various medications or
drugs being taken by older adults is to use the brown-bag
technique to obtain that information from the patient or
caregiver. This is an effective means of identifying various
drugs that the patient is taking, regardless of the patient’s age,
and may be used in conjunction with a complete review of
the patient’s medical history or record. The brown-bag technique requires the patient or caregiver to place all medications used in a bag and bring them to the health care provider.
All medications need to be brought in their original containers. A list of medications with generic names, dosages, routes
of administration, and frequencies is then compiled and the
list is then compared with what is prescribed and what the
patient states is actually being taken. Medication reconciliation procedures are performed in health care facilities when
CHAPTER 4 Patient-Focused Considerations
Cultural Assessment Tools and
Related Weblinks
BOX 4.1
• Madeline Leininger’s Sunrise Model focuses on seven major areas of cultural assessment, including educational; economic; familial and social;
political; technological; religious and philosophical; and cultural values,
beliefs, and practices.
• Other comprehensive cultural assessment tools include those developed by Andrews and Bowls, 2008; Friedman, Bowles, and Jones,
2003; Giger and Davidhizar, 2002; and Purnell and Paulanka, 1998.
Rani Srivastava’s (2006) model, found in The Healthcare Professional’s Guide to Clinical Cultural Competence (Healthcare Professional’s
Guides), contains further discussion on how populations are viewed
by health care workers and not through the use of ethnocultural or
religious labels.
assessing and tracking medications taken by the patient (see
Chapter 6).
With older adults, thoroughly assess support systems and
the patient’s ability to take medications safely. Other data to
collect include information about acute or chronic illnesses,
nutritional problems, heart problems, respiratory illnesses,
and gastrointestinal tract disorders. Laboratory tests that are
often ordered for older adults include hemoglobin and hematocrit levels, red blood cell and white blood cell counts, serum
electrolyte levels, protein and serum albumin levels, blood
urea nitrogen level, serum and urine creatinine levels, and
urine specific gravity.
Ethnocultural Considerations
A thorough ethnocultural assessment is needed for the provision of ethnoculturally competent nursing care. A variety
of assessment tools and resources to incorporate into nursing
care are provided in Box 4.1. However, various factors must
be assessed and then applied to nursing care, specifically drug
therapy and the nursing process. Some of the specific questions
to consider about the patient’s physical, mental, and spiritual
health include the following:
Maintaining Health
• For physical health: Where are special foods and clothing
items purchased? What types of health education are of the
patient’s ethnoculture? Where does the patient usually obtain
information about health and illness? Folklore? Where are
health services obtained? Who are the health care providers
(e.g., physicians, nurse practitioners, community services,
health departments, healers)?
• For mental health: What are examples of ethnoculturally
specific activities for the mind and for maintaining mental
health, as well as beliefs about rest, relaxation, and reducing
stress?
• For spiritual health: What resources are used to meet spiritual needs?
Protecting Health
• For physical health: Where are special clothing and everyday essentials purchased? What are examples of the patient’s
symbolic clothing, if any?
61
• For mental health: Who within the family and community teaches the roles in the patient’s specific ethnoculture? Are there rules about avoiding certain persons or
places? Are there special activities that must be performed?
• For spiritual health: Who teaches spiritual practices and
where can special protective symbolic objects such as crystals or amulets be purchased? Are they expensive and how
available are they for the patient when needed?
Restoring Health
• For physical health: Where are special remedies purchased
Can individuals produce or grow their own remedies, herbs,
and so on? How often are traditional and nontraditional services obtained? Is the process and medication ethnoculturally safe for this patient?
• For mental health: Who are the traditional and nontraditional resources for mental health? Are there ethnoculture-specific activities for coping with stress and illness?
• For spiritual health: How often and where are traditional and
nontraditional spiritual leaders or healers accessed?
NURSING DIAGNOSES: AGE-RELATED
• Imbalanced nutrition, less than body requirements, resulting from the impact of age and drug therapy and possible
adverse effects
• Inadequate knowledge resulting from information about
drugs and their adverse effects or about when to contact the
prescriber
• Potential for injury resulting from adverse effects of medications or from the method of drug administration
• Potential for injury resulting from idiosyncratic reactions to
drugs as a result of age-related drug sensitivity
PLANNING
Goals
• Patient (caregiver, parent, or legal guardian) will state measures to enhance nutritional status due to age- and drug-related factors, as well as any adverse drug effects on everyday
nutrition.
• Patient (caregiver, parent, or legal guardian) will state
the importance of adhering to the prescribed drug therapy (or will take medication as prescribed with assistance).
• Patient will contact the prescriber when appropriate, such as
when unusual effects occur during drug therapy.
• Patient (caregiver, parent, or legal guardian) will identify
ways to minimize complications, adverse effects, reactions,
and injury associated with the therapeutic medication regimen.
Expected Patient Outcomes
• Patient (caregiver, parent, or legal guardian) lists recommended caloric and protein intake as well as examples of all
the major food groups with the assistance of nutritional consultation.
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PART 1 Pharmacology Basics
• Patient (caregiver, parent, or legal guardian) identifies when
to contact the prescriber if nausea, vomiting, loss of appetite,
diarrhea, constipation, or other problems arise during medication therapy.
• Patient (caregiver, parent, or legal guardian) states rationale
for medication as well as importance in the timing, dosage,
and duration of therapy and is able to identify what the specific medication looks like.
• Patient (caregiver, parent, or legal guardian) describes
intended therapeutic effects of the medication(s), such as
improvement in condition with decrease in symptoms and
with limited adverse effects.
• Patient (caregiver, parent, or legal guardian) demonstrates
safe method of self- or assisted medication administration,
such as use of a week-long pill mechanism (e.g., blister pack
or a dosette medication box) with day of week and associated
times, and has all medications safely labelled.
• Patient (caregiver, parent, or legal guardian) follows instructions specific to the route of administration for the medication
ordered, while also demonstrating (if appropriate) techniques,
such as special application of an ointment as prescribed, measuring and taking liquid medication, and taking medication
with proper food or fluids, for the duration of treatment.
• Patient (caregiver, parent, or legal guardian) lists the most
frequent adverse effects and possible toxicity associated with
medication regimen, while also stating when to contact the
health care provider, such as occurrence of fever, pain, vomiting, rash, diarrhea, difficulty breathing, or worsening of the
condition being treated.
• Patient (caregiver, parent, or legal guardian) reports safe
medication administration upon return appointment after
beginning prescribed therapy.
• Patient (caregiver, parent, or legal guardian) minimizes
adverse effects and danger to self by taking medication(s)
as prescribed, at the right time, with right dosing, and with
attention to intake of proper amount of fluids (120 to 180 mL
of water with oral dosages) and with or without food, as indicated, while remaining aware of safety measures appropriate
to specific drug regimen.
IMPLEMENTATION
It is always important to emphasize and practise the Ten Rights
of medication administration (see Chapter 1) and follow the
prescriber’s order and medication instructions. Check all drugs
three times against the Ten Rights and the prescriber’s order
before the drug is given to the patient. This usually applies in
acute care and long-term care inpatient and outpatient situations. For pediatric patients, some specific nursing actions are
as follows: (1) If needed, mix medications in a substance or
fluid other than essential foods (e.g., milk, orange juice, cereal)
to avoid causing the child to develop a dislike for the essential
food in the future. Instead, use a liquid or food item that may
be used to make the medication(s) taste better, such as sherbet or flavoured ice cream. Use this intervention only if the
patient cannot swallow the dosage form or if the taste needs
to be made more palatable. (2) Do not add drug(s) to fluid in
a cup or bottle because the amount of drug consumed would
then be impossible to calculate if the entire amount of fluid is
not consumed. (3) Always document special techniques of drug
administration so that others involved in the patient’s care may
benefit from the suggestion. For example, if the child takes an
unpleasant-tasting pill, liquid, or tablet after eating a frozen
Popsicle, then this information would be valuable to another
caregiver. (4) Unless contraindicated, add small amounts of
water or fluids to elixirs to enhance the child’s tolerance of the
medication. Remember that it is essential for the child to take
the entire volume, so remain cautious with this practice and
use only an amount of fluid mixture that you know the child
will tolerate. (5) Avoid using the word candy in place of drug
or medication. Medications must be called medicines and their
dangers made known to children. Taking medications is not a
game, and children must understand this for their own safety.
(6) Keep all medications out of the reach of children of all ages.
Be sure that parents and other family members in the same
household understand this information and request child-protective lids or tops for their medications from the pharmacy.
Also, childproof locks or closures may be used on cabinets holding medications. (7) Inquire about how the child usually takes
medication (e.g., preference of liquid versus pill or tablet dosage
forms) and whether there are any methods from the family or
caregiver that may be helpful. See Special Populations: Children
box, on page 49, for recommendations and further information
on medication administration, beginning with infancy through
adolescence. For more information about dosage calculations
for medication administration in pediatric patients, visit the
TestandCalc website, which provides examples and programs
to help with pediatric drug dosage calculations (http://www.
testandcalc.com).
Encourage older adult patients to take medications as
directed and not to discontinue them or double up on doses
unless recommended or ordered to do so by their health care
provider or prescriber. The patient or caregiver must understand the treatment- and medication-related instructions,
especially those resulting from safety measures such as keeping all medications out of the reach of children. Transdermal
patches provide a different challenge in that if they fall off onto
the floor or bedding, a child or infant in that environment
may have accidental exposure to the effects of the medication.
Serious adverse reactions have been reported concerning the
accidental adhering of a transdermal patch to a child or infant
while crawling or playing on the floor or carpet. Toxic and
even fatal reactions may occur, depending on the medication
and dosage. Provide written and verbal instructions concerning the drug name, action, purpose, dose, time of administration, route, adverse effects, safety of administration, storage,
interactions, and any cautions about or contraindications to
its use. Remember that simple is always best. Always try to
find ways to make the patient’s therapeutic regimen easy to
understand. Always be alert to polypharmacy and be sure the
patient or caregiver understands the dangers of multiple drug
use. Patient education may prove to be helpful in preventing or minimizing problems associated with polypharmacy.
If a nurse advocate or a nurse practitioner with prescription
CHAPTER 4 Patient-Focused Considerations
privileges has the opportunity to review the patient’s chart, she
or he must provide simplified written instructions outlining
the purpose of the drug, how to best take the medication(s),
and a list of drug interactions and adverse effects. Information
must be provided in bold, large print. The Beers Criteria have
proven helpful in promoting medication safety in older adults
(see Evidence In Practice box on page 55). These criteria provide a systematic way of identifying prescription medications
that are potentially harmful to older adults. The prescriber and
nurse must constantly remember that clinical judgement and
knowledge base are important in making critical decisions
about a patient’s care and drug therapy. In addition, keeping
abreast of evidence-informed nursing practice, such as the
application of the Beers Criteria, is important for the nurse
to remain current in clinical nursing practice. Specific guidelines for medication administration by different routes are
presented in detail in Chapter 10.
In summary, drug therapy across the lifespan must be well
thought out, with full consideration to the patient’s age, gender, ethnocultural background, medical history, and medication profile. When all phases of the nursing process and
the specific lifespan considerations discussed in this chapter
are included, there is a better chance of decreasing adverse
effects, reducing risks to the patient, and increasing drug
safety.
EVALUATION
When dealing with lifespan issues resulting from drug therapy, observation and monitoring for therapeutic effects as well
as adverse effects are critical to safe and effective therapy. The
nurse must know a patient’s profile and history just as well as
information about the drug. The drug’s purpose, specific use
in the patient, simply stated actions, dose, frequency of dosing,
adverse effects, cautions, and contraindications need to be listed
and kept available at all times. This information will allow more
comprehensive monitoring of drug therapy, regardless of the
age of the patient.
NURSING DIAGNOSES: ETHNOCULTURAL
• Sleep deprivation resulting from a lack of adherence to
cultural practices for encouraging stress release and sleep
induction
• Inadequate knowledge (drug therapy) resulting from lack of
experience and information about prescribed drug therapy
• Potential for injury resulting from adverse and unpredictable
reaction to drug therapy due to racial or ethnic cultural factors
PLANNING
Goals
• Patient will state the need for assistance with nonpharmacological management of sleep deficit.
• Patient will request written and verbal education about medication therapy.
63
CASE STUDY
Polypharmacy and Older Adults
Rhonda, a 77-year-old retired librarian, sees several
physician specialists for a variety of health problems.
She uses the pharmacy at a large discount store but
also has prescriptions filled at a nearby pharmacy,
which she uses when she does not feel like going
into the larger store. Her medication list is as follows:
Thiazide diuretic, prescribed for peripheral edema
Potassium tablets, prescribed to prevent hypokalemia
beta blocker, prescribed for hypertension
Warfarin sodium, taken every evening because of a history of deep vein
thrombosis
Thyroid replacement hormone for hypothyroidism
Multivitamin tablet for seniors
1. What medications may cause problems for Rhonda? Explain your answer.
2. What measures can be taken to reduce these problems?
Rhonda visits the pharmacy to pick up some medications for a cold. She
has chosen a popular OTC decongestant, an antihistamine preparation, and a
nonsteroidal anti-inflammatory drug for her “aches and pains.”
3. Should she use these medications? If not, what advice would you give her
about choosing OTC medications?
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
• Patient will state need for information about the influence of
racial or ethnic cultural factors upon specific drug therapy,
with emphasis on safety measures.
Expected Patient Outcomes
• Patient describes specific measures to enhance sleep patterns,
such as regular sleep habits, decrease in caffeine, meditation,
relaxation therapy, and journaling sleep patterns and noting
those measures that enhance or take away sleep.
• Patient lists the various medication(s) with their therapeutic and adverse effects, dosage routes, and specific methods
of adequate self-administration, drug interactions, and any
other special considerations.
• Patient describes the impact of racial or ethnic influences (e.g.,
metabolic enzyme differences) on specific medications and
the resulting potential for increase in adverse effects, toxicity,
or increased or decreased effectiveness (medication therapy).
IMPLEMENTATION
There are numerous interventions for implementation of ethnoculturally competent nursing care, but one important requirement is that nurses remain current in the knowledge of various
ethnocultures and related activities and practices of daily living,
health beliefs, as well as emotional and spiritual health practices
and beliefs. Specifically, knowledge about medications that may
elicit varied responses due to racial or ethnic variations is most
important, along with application of concepts of culturally competent care and ethnopharmacology for each patient care situation.
Information of significance is the impact of cytochrome
P450 liver enzymes on certain phases of drug metabolism.
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PART 1 Pharmacology Basics
Specific examples of differences in certain cytochrome P450
enzymes can be found. Consider additional factors, including
the patient’s verbal and nonverbal communication patterns;
the patient’s health belief systems; identification of health care
providers or alternate healers; and the patient’s interpretation
of space, time, and touch. For example, cost may be a consideration in regard to adherence with the treatment regimen.
Other lifestyle decisions (e.g., use of tobacco or alcohol) may
also affect responses to drugs and must be considered during
drug administration. In addition, a patient’s ethnocultural
background and associated socioeconomic status may create a
situation that leads the patient to skip pills, split doses, and not
obtain refills. This culture of poverty may be a causative factor
in nonadherence and requires astute attention and individualized nursing actions.
EVALUATION
Ethnoculturally competent nursing care regarding drug therapy may be evaluated through adherence (or nonadherence)
to the medication regimen(s). Safe, effective, and therapeutic
self-administration of drugs with minimal to no adverse or
toxic effects will be present only when the patient is treated as
an individual and has a thorough understanding of the medication regimen.
CASE STUDY
Otitis Media in a Child
A parent brings her 2-year-old son, Bryson, to the
community health clinic with reports of fussiness
and tugging at his left ear for the past 48 hours. He
has been coughing and has had a runny nose for 4
days that has been treated with saline nose sprays
and use of a humidifier. He had a low-grade fever of
38.4°C axillary for the past 48 hours. It has now risen
to 39°C. Bryson attends day care and both parents
smoke cigarettes. Bryson’s past medical history is
significant for bilateral ear infections, with his last
episode 5 months ago, which was treated with amoxicillin. His immunizations
are up to date, including 13-valent pneumococcal conjugate vaccine. He is
diagnosed with acute otitis media and prescribed amoxicillin and ibuprofen.
1. What characteristics of pediatric patients may have a significant effect on
dosage calculation?
2. What pharmacokinetic factors may affect the administration of the ordered
drugs for Bryson?
3. Bryson’s mother is concerned that he has had a few episodes of otitis media.
What health teaching would the nurse undertake with Bryson’s mother?
4. Bryson weighs 11.5 kg. The recommended dose of amoxicillin to treat otitis media
is 75 to 90 mg/kg/day divided bid. What dose range is appropriate for Bryson?
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
KEY POINTS
• There are many age-related pharmacokinetic effects that
lead to dramatic differences in drug absorption, distribution,
metabolism, and excretion in young people and older adults.
At one end of the lifespan is the pediatric patient, and at the
other is older adult patients, both of whom are sensitive to
the effects of drugs.
• For pediatrics, most common dosage calculations use the
milligrams per kilogram formula pertaining to age; however,
BSA is also used for drug calculations, and organ maturity is
considered. It is important for the nurse to know that many
elements besides the mathematical calculation contribute to
safe dosage calculations. Safety must remain the number one
concern, with consideration of the Ten Rights of medication
administration (see Chapter 1).
• The percentage of the population older than 65 years of age
continues to grow, and polypharmacy remains a concern
with the increasing number of older adult patients. For older
adults, a current list of all medications and drug allergies must
always be on their person or with their family/caregiver.
• The nurse’s responsibility is to act as a patient advocate as
well as to be informed about growth and developmental
principles and the effects of various drugs during the lifespan
and in various phases of illness.
• A variety of culturally based assessment tools are available
for use in patient care and drug therapy.
• Drug therapy and subsequent patient responses may be
affected by racial and ethnic variations in levels of specific
enzymes and metabolic pathways of drugs.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. The nurse is reviewing factors that influence pharmacokinetics in the neonatal patient. Which factor puts the neonatal patient at risk as related to drug therapy?
a. Immature renal system
b. Hyperperistalsis in the gastrointestinal tract
c. Irregular temperature regulation
d. Smaller circulatory capacity
2. The physiological differences in the pediatric patient compared with the adult patient affect the amount of drug
needed to produce a therapeutic effect. The nurse is aware
that one of the main differences is that infants have which of
the following?
a. Increased protein in circulation
b. Fat composition less than 0.001%
c. More muscular body composition
d. Water composition of approximately 75%
3. While teaching 76-year-old Rahul about the adverse effects
of his medications, the nurse encourages him to keep a
journal of the adverse effects he experiences. This intervention is important for older adult patients because of which
alterations in pharmacokinetics?
a. Increased kidney excretion of protein-bound drugs
b. More alkaline gastric pH, resulting in more adverse
effects
CHAPTER 4 Patient-Focused Considerations
c. Decreased blood flow to the liver, resulting in altered
metabolism
d. Less adipose tissue to store fat-soluble drugs
4. The nurse is reviewing a list of medications taken by Huang,
an 88-year-old patient. Huang says, “I get dizzy when I
stand up.” She also states that she has nearly fainted “a time
or two” in the afternoons. Her systolic blood pressure drops
15 points when she stands up. Which type of medications
may be responsible for these effects?
a. NSAIDs
b. Cardiac glycosides
c. Anticoagulants
d. Antihypertensives
5. A woman who is pregnant asks the nurse at the health care
clinic how to know which drugs are safe to take during
pregnancy. What is the nurse’s best response?
a. “Continue to take any drugs previously prescribed
by your health care provider as there are few studies
to establish which drugs are safe to take during pregnancy.”
b. “It is safe to continue taking the over-the-counter drugs
that you are currently taking.”
c. “It is advisable not to take any prescription or over-thecounter drugs while pregnant.”
d. “It is best to consult with your health care provider
about taking any prescription or over-the-counter
drugs.”
6. The nurse is preparing to administer an injection to a preschool-age child. Which approaches are appropriate for
this age group? (Select all that apply.)
a. Explain to the child in advance about the injection.
b. Provide a brief, concrete explanation about the injection.
c. Encourage participation in the procedure.
d. Make use of magical thinking.
e. Provide comfort measures after the injection.
65
7. Yuri, a patient of Japanese descent, describes a family
trait that manifests frequently—she says that members of
her family often have “strong reactions” after taking certain medications, but her friends who are not of Japanese
descent have no problems with the same dosages of the
same medications.
a. Yuri may need lower dosages of the medications prescribed.
b. Yuri may need higher dosages of the medications prescribed.
c. Yuri should not receive these medications because of
potential problems with metabolism.
d. These situations vary greatly, and Yuri’s accounts may
not indicate a valid cause for concern.
8. Which factors does the nurse consider when evaluating
polymorphism and medication administration? (Select all
that apply.)
a. Nutritional status
b. Drug route
c. Patient’s ethnicity
d. Cultural beliefs
e. Patient’s age
9. The nurse is preparing to give an oral dose of acetaminophen (Tylenol®) to a child who weighs 12 kg. The dose is 15
mg/kg. How many milligrams will the nurse administer for
this dose?
10. An 82-year-old patient is admitted to the hospital after an
episode of confusion at home. The nurse is assessing the
current medications he is taking at home. Which method is
the best way to assess his home medications?
a. Ask the patient what medications he takes at home.
b. Ask the patient’s wife what medications he takes at
home.
c. Ask the patient’s wife to bring his medications to the
hospital in their original containers.
d. Contact the patient’s pharmacy for a list of the patient’s
current medications.
CRITICAL THINKING ACTIVITIES
1. A mother calls the clinic to ask how to give a tablet to her
4-year-old son. He is refusing to swallow it and will not chew
it because it “tastes icky.” The mother says she is ready to
force her son to take this medication. What is the nurse’s priority action?
2. A woman in her third trimester of pregnancy is having a
checkup and asks for acetylsalicylic acid (ASA) for a headache. What is the nurse’s best response?
3. A 22-year-old woman has brought her 16-month-old daughter to see the nurse practitioner because the toddler has
symptoms of a sinus infection. After examining the toddler,
the nurse practitioner writes a prescription for an antibiotic. The mother says, “Oh, I have tetracycline suspension
at home that I took for an infection. Can’t I just use that and
save money?” What is the nurse’s best answer?
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
•
•
•
•
Website
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
• Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
66
PART 1 Pharmacology Basics
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Journal of Neuroscience Nursing, 45(2), 63–70.
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5
Gene Therapy and Pharmacogenomics
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Identify the significance of the basic terms related to
genetics and drug therapy.
2. Briefly discuss the major concepts of genetics as an
evolving segment of health care, such as principles of
genetic inheritance; deoxyribonucleic acid (DNA),
ribonucleic acid (RNA), and their functioning; the
relationship of DNA to protein synthesis; and the
importance of amino acids.
3. Describe the basis of the Human Genome Project and its
impact on the role of genetics in health care.
4. Discuss the gene therapies currently available.
5. Differentiate between the direct and indirect forms of gene
therapy.
6. Identify the regulatory and ethical issues resulting from
gene therapy as well as nursing and health care providers.
7. Briefly discuss pharmacogenomics and pharmacogenetics.
8. Discuss the evolving role of professional nurses and gene
therapy.
KEY TERMS
Acquired disease Any disease triggered by external factors and
not directly caused by a person’s genes (e.g., an infectious
disease, noncongenital cardiovascular diseases). (p. 68)
Alleles The two alternative forms of a gene that can
occupy a specific locus (location) on a chromosome (see
chromosome). (p. 68)
Chromatin A collective term for all of the chromosomal
material within a given cell. (p. 69)
Chromosome Structure in the nuclei of cells that contains
threads of deoxyribonucleic acid (DNA), which transmit
genetic information, and that are associated with
ribonucleic acid (RNA) molecules and synthesis of protein
molecules. (p. 68)
Gene The biological unit of heredity; a segment of a DNA
molecule that contains all of the molecular information
required for the synthesis of a biological product such as an
RNA molecule or an amino acid chain (protein molecule).
(p. 68)
Gene therapy New therapeutic technologies that directly
target human genes in the treatment or prevention of
illness. (p. 70)
Genetic disease Any disorder caused by a genetic mechanism.
(p. 68)
Genetic material DNA or RNA molecules or portions of
them. (p. 68)
Genetic polymorphisms Variants that occur in the
chromosomes of 1% or more of the general population
(i.e., too frequently to be caused by a random recurrent
mutation). (p. 71)
Genetic predisposition The presence of certain factors in a
person’s genetic makeup, or genome (see next page), that
increases the likelihood of developing one or more diseases.
(p. 68)
Genetics The study of the structure, function, and inheritance
of genes. (p. 69)
Genome The complete set of genetic material of any organism.
It may be contained in multiple chromosomes (groups of
DNA or RNA molecules) in higher organisms; in a single
chromosome, as in bacteria; or in a single DNA or RNA
molecule, as in viruses. (p. 69)
Genomics The study of the structure and function of the
genome, including DNA sequencing, mapping, and
expression, and the way genes and their products work in
both health and disease. (p. 69)
Genotype The particular alleles present at a given site (locus)
on the chromosomes of an organism that determine a
specific genetic trait for that organism (compare phenotype).
(p. 68)
Heredity The characteristics and qualities that are genetically
passed from one generation to the next through
reproduction. (p. 69)
Inherited disease Genetic disease that results from defective
alleles passed from parents to offspring. (p. 68)
Nucleic acids Molecules of DNA or RNA in the nucleus of
every cell. DNA makes up the chromosomes and encodes
the genes. (p. 68)
Personalized medicine The use of molecular-level and genetic
characterizations of both the disease process and the patient
for the customization of drug therapy. (p. 71)
Pharmacogenetics The study of the genetic basis for
variations in the body’s response to drugs, with a focus on
variations resulting from a single gene. (p. 71)
Pharmacogenomics A branch of pharmacogenetics (see
earlier) that involves the survey of the entire genome to
detect multigenic (multiple-gene) determinants of drug
response. (p. 71)
67
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PART 1 Pharmacology Basics
Phenotype The expression in the body of a genetic trait that
results from a person’s particular genotype (see earlier) for
that trait. (p. 68)
Proteome The entire set of proteins produced from the
information encoded in an organism’s genome. (p. 69)
Proteomics The detailed study of the proteome, including all
biological actions of proteins. (p. 69)
Recombinant DNA (rDNA) DNA molecules that have been
artificially synthesized or modified in a laboratory setting.
(p. 70)
OVERVIEW
which proteins are made. Humans normally have 23 pairs of
chromosomes in each of their somatic cells, which are the cells
in the body other than the sex cells (sperm cells or egg cells),
which have 23 single (unpaired) chromosomes. One pair of
chromosomes in each cell is termed the sex chromosomes,
which can be designated as either X or Y. The sex chromosomes are normally XX for females and XY for males. One
member of each pair of chromosomes in somatic cells comes
from the father’s sperm cell and one from the mother’s egg.
Alleles are the alternative forms of a gene that can vary in
regard to a specific genetic trait. Genetic traits can be desirable (e.g., lack of allergies) or undesirable (e.g., predisposition
toward a specific disease). Alleles are dominant or recessive.
Each person has two alleles for every gene-coded trait—one
allele from the mother, the other from the father. An allele may
be dominant or recessive for a given genetic trait. The particular combination of alleles, or genotype, for a given trait
determines whether or not a person manifests that trait, or
the person’s phenotype. Genetic traits that are passed on differently to male and female offspring are said to be sex-linked
traits because they are carried on either the X or Y chromosome. For example, hemophilia genes are carried by females
but manifest as a bleeding disorder only in males. Hemophilia
is an example of an inherited disease; that is, a disease caused
by passage of a genetic defect from parents to offspring. A
more general term is genetic disease, which is any disease
caused by a genetic mechanism. Note, however, that not all
genetic diseases are inherited. Chromosomal abnormalities
(aberrations) can also occur spontaneously during embryonic
development. In contrast, an acquired disease is any disease
that develops in response to external factors and is not directly
resulting from a person’s genetic makeup. Genetics can play an
indirect role in acquired disease, however. For example, atherosclerotic heart disease is often acquired in middle or later
life. Many people have certain genes in their cells that increase
the likelihood of this condition. This is known as a genetic
predisposition. In some cases, a person may be able to offset a genetic predisposition through lifestyle choices, such as
consuming a healthy diet and exercising to lessen the risk of
developing heart disease.
Current literature differentiates “old genetics,” which focused
on single-gene inherited diseases such as hemophilia, from “new
genetics.” The new genetic perspective recognizes that common
diseases, including Alzheimer’s disease, cancer, and heart disease, are the product of complex relationships between genetic
and environmental factors. These environmental factors, such
as diet or toxic exposures, can initiate or worsen disease processes. Research into disease treatment is beginning to look at
genetically tailored therapy.
Genetic processes are a highly complex part of physiology and
are far from being completely understood. Genetic research
is one of the most active branches of science today, involving
many types of health care providers, including nurses. Expected
outcomes of this research include a deeper knowledge of the
genetic influences on disease, along with the development
of gene-based therapies. The practice of nursing requires an
understanding of genetic concepts as well as genetically related
health issues and therapeutic techniques. The goal of this chapter is to introduce some of the major concepts of this complex
and emerging branch of health science. In 1996, in the United
States, the National Coalition for Health Professional Education
in Genetics (NCHPEG) was founded. Although NCHPEG
closed in 2013, its purpose was to promote the education of
health professionals and the public regarding advances in
applied genetics. The Jackson Laboratory (JAX) now runs
and maintains all NCHPEG education materials and the website and has adopted the baseline competencies (The Jackson
Laboratory, 2019).
Since the 1960s, published literature has described the
role of nursing in genetics and genetic research. The Genetics
Nursing Network was formed in 1984 and later became the
International Society of Nurses in Genetics (ISONG). The
Canadian Nurses Association recognized the importance of
knowledge of genetics in nursing in 2005, yet it is still not
an official nursing specialty. The growing understanding of
genetics is quickly creating demand for clinicians in all fields
who can educate patients and provide clinical care that tailors health care services to each patient’s inherent genetic
makeup. This reality also calls for increasing the level of
genetics education in nursing school curricula as well as in
continuing nursing education. Interestingly, the study of
genetics has become commonplace in secondary and even
primary education.
BASIC PRINCIPLES OF GENETIC INHERITANCE
Nucleic acids are biochemical compounds consisting of two
types of molecules: deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). DNA molecules make up the genetic
material that is passed between all types of organisms during
reproduction. In some viruses (e.g., human immunodeficiency virus [HIV]), it is actually RNA molecules that pass the
virus’s genetic material between generations; however, this is
an exception to the norm. A chromosome is a long strand of
DNA contained in the nuclei of cells. DNA molecules, in turn,
act as the template for the formation of RNA molecules, from
CHAPTER 5 Gene Therapy and Pharmacogenomics
DISCOVERY, STRUCTURE, AND FUNCTION OF
DNA
Genetics is the study of the structure, function, and inheritance of genes. Heredity refers to the qualities that are genetically transferred from one generation to the next during
reproduction.
A major turning point in the current understanding of
genetics came in 1953, when Drs. James Watson and Francis
Crick first reported the chemical structures of human genetic
material and named the primary biochemical compound deoxyribonucleic acid (DNA). They later received a Nobel Prize for
their discovery.
It is now recognized that DNA is the primary molecule in the
body that serves to transfer genes from parents to offspring. It
exists in the nucleus of all body cells as strands of chromosomes,
collectively called chromatin. As described in Chapter 40, DNA
molecules contain four different organic bases, each of which
has its own alphabetical designation: adenine (A), guanine (G),
thymine (T), and cytosine (C). These bases are linked to a type of
sugar molecule known as deoxyribose. In turn, these sugar molecules are linked to a “backbone” chain of phosphate molecules,
which results in the classic double-helix structure of two sideby-side, spiral macromolecular chains. An important related
biomolecule is ribonucleic acid (RNA). RNA has a chemical
structure similar to that of DNA, except that its sugar molecule
is the compound ribose instead of deoxyribose, and it contains
the base uracil (U) in place of thymine. RNA more commonly
occurs as a single-stranded molecule, although in some genetic
processes it can also be double stranded. In double-stranded
structures, the base of each strand binds (via hydrogen bonds)
to that of the other strand in the space between the two strands.
This binding is based on complementary base pairing determined by the chemistry of the base molecules themselves.
Specifically, adenine can bind only with thymine or uracil,
whereas cytosine can bind only with guanine.
A nucleotide is the structural unit of DNA and consists of
a single base and its attached sugar and phosphate molecules.
A nucleoside is the base and attached sugar without the phosphate molecule. A relatively small sequence of nucleotides is
called an oligonucleotide (the prefix oligo- means “a small number”). Certain new drug therapies involve synthetic analogues
of both nucleosides and nucleotides (see Chapters 45, 49, 50,
and 51). A related field is targeted drug therapy. Targeted drug
therapy focuses on modifying the function of immune system cells (T cells and B cells) and biochemical mediators of
immune response (cytokines). However, it is expected to focus
on modifying specific genes as well. Current examples of targeted drug therapy are presented in Chapters 49, 50, 52, and 53.
One of these drugs, the ophthalmic antiviral drug fomivirsen
(not available in Canada), is an oligonucleotide with a chemical
structure that is opposite (complementary) to that of a critical
part of the messenger RNA (mRNA) of the cytomegalovirus.
For this reason, it is called an antisense oligonucleotide, and it
is the first of this new class of drugs. Other types of antisense
oligonucleotide drugs are anticipated in the near future as one
type of gene therapy.
69
An organism’s entire DNA structure is its genome. This word
is a combination of the terms gene and chromosome, and it refers
to all the genes in an organism taken together. Genomics is the
relatively new science of determining the location (mapping),
structure (DNA base sequencing), identification (genotyping),
and expression (phenotyping) of individual genes among the
entire genome, and determining their functions in both health
and disease processes.
Protein Synthesis
Protein molecules drive the functioning of all biochemical
reactions. Protein synthesis is the primary function of DNA
in human cells. There is a direct relationship between DNA
nucleotide sequences and corresponding amino acid sequences.
This relationship allows for precision in protein synthesis.
Interestingly, it is estimated that only 2 to 3% of the human
genome is involved in protein synthesis. Amino acid sequences
control the shape of protein molecules, which ultimately affects
their ability to function in the body. Mutations, undesired
changes in DNA sequence, can affect the shape of protein molecules and impair or destroy their functioning.
In the cell nuclei, the double strands of DNA uncoil and separate, and a strand of mRNA forms on each strand through complementary base pairing, as described earlier in the chapter. This
process is called transcription of the DNA. These mRNA molecules then detach from their corresponding DNA strands, leave
the cell nucleus, and enter the cytoplasm, where they are then
“read,” or translated, by the ribosomes. Ribosomes are composed
of a second type of RNA, known as ribosomal RNA (rRNA),
as well as several accessory proteins. Individual sequences of
three bases along the mRNA molecule serve to code for specific
amino acid molecules. This translation process involves molecules of a third type of RNA, transfer RNA (tRNA). The tRNA
molecules transport the corresponding amino acid molecules
to the site of ribosomal translation along the mRNA strand in
sequence, according to the three-base codes along the mRNA
strand. This in turn results in the creation of chains of multiple
amino acid molecules (polypeptide chains), which are known
as protein molecules. The specificity of this code is important for
proper protein synthesis and the process is similar for all living
organisms—plant and animal.
There are countless specific amino acid sequences (polypeptides) that result in the synthesis of many thousands of types
of protein molecules. Proteins include hormones, enzymes,
immunoglobulins, and numerous other biochemical molecules
that regulate processes throughout the body. They are involved
in both healthy physiological processes and the pathophysiological processes of many diseases. Biomedical researchers
continue to identify and describe many proteins that are part of
disease processes. Manipulation of genetic material, as in gene
therapy (see later in this chapter), can theoretically modify the
synthesis of these proteins and therefore aid in the treatment of
disease. This emerging science continues to give rise to novel
terminology. The entire set of proteins produced by a genome
is now known as the proteome. Proteomics is the study of the
proteome, including protein expression, modification, localization, and function, as well as the protein–protein interactions
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PART 1 Pharmacology Basics
that are part of biological processes. This science is expected to
provide new drug therapies in the future. Furthermore, most
clinically approved drugs interact with body proteins such as
cell membrane receptors, hormones, and enzymes.
In Vitro Manipulation
Viral
vector
Human Genome Project
In 1990, an unprecedented genetic research project began,
known as the Human Genome Project (HGP). This project
was a worldwide research initiative coordinated by the U.S.
Department of Energy and the National Institutes of Health
(NIH). The project was completed in 2003, 2 years ahead of
schedule. The goals of this project were to identify the estimated
30 000 genes—3 billion base pairs—in the DNA of an entire
human genome. Additional goals included developing new
tools for genetic data analysis and storage, transferring newly
developed technologies to the private sector, and addressing
the inherent ethical, legal, and social issues involved in genetic
research and clinical practice. However, the ultimate goal was
to develop improved prevention, treatment, and cures for disease. When the HGP began, there were 100 known human, disease-related genes. By its completion, there were 1 400.
GENE THERAPY
Background
Gene therapy is an experimental technique that uses genes to
treat or prevent disease. It allows doctors to treat a disorder by
inserting a gene into a patient’s cells instead of using drugs or
surgery. Researchers are testing several approaches to gene therapy, including the following:
• Replacing a mutated gene with a healthy copy of the gene
• Introducing a new gene into the body to help fight a disease
• Inactivating a mutated gene that is functioning improperly
Gene therapy research is based on the ongoing discovery of
new details regarding cellular processes, including biochemical processes that occur at the molecular level. In addition, the
increased understanding of allelic variation and its role in disease susceptibility can be used to guide attempts at preventive
therapy based on a person’s genotypic risk factors.
Although numerous gene therapy clinical trials have been
approved by Health Canada, no gene therapy to date has been
approved for routine treatment of disease. The goal of gene
therapy is to transfer exogenous genes that will either provide
a temporary substitute for, or initiate permanent changes in
the patient’s own genetic functioning to treat a given disease.
Originally projected to provide treatment primarily for inherited genetic diseases, gene therapy techniques are now being
researched for the treatment of acquired illnesses such as cancer, cardiovascular diseases, diabetes, infectious diseases, and
substance misuse. In the future, in-utero gene therapy may be
used to prevent the development of serious diseases as part of
the prenatal care for the unborn fetus.
Description
During gene therapy, segments of DNA are injected into the
patient’s body in a process called gene transfer. These artificially
produced DNA splices are also known as recombinant DNA
(rDNA) and must usually be inserted into some kind of carrier
Proliferation
Therapeutic
ADA gene
Dysfunctional
ADA gene
Self-replication
Corrected Cell
Fig. 5.1 Gene therapy for adenosine deaminase (ADA) deficiency
attempts to correct this immunodeficiency state. The viral vector
containing the therapeutic gene is inserted into the patient’s lymphocytes. These cells can then make the ADA enzyme. From Lewis,
S. M., Dirksen, S. R., Heitkemper, M. M., et al. (2014). Medical-surgical
nursing in Canada: Assessment and management of clinical problems
(3rd ed.). (Canadian Eds. S. Goldsworthy, M. Barry, & D. Goodridge).
Toronto, ON: Elsevier Mosby.)
or vector for the gene transfer process. Vectors currently being
evaluated include spherical lipid compounds known as liposomes, free DNA splices known as plasmids, DNA conjugates
in which DNA splices are linked (conjugated) to either protein
or gold particles, and various types of viruses. Viruses are the
most widely studied rDNA vectors thus far. One commonly
used group of viruses is that of the adenoviruses, which includes
human influenza viruses.
Limitations
Viruses used for gene transfer can also induce viral disease and
be immunogenic in the human host. The proteins produced
by such artificial methods can be immunogenic. Even in the
absence of significant virus-induced disease, the positive effects
(e.g., supplemented protein synthesis) may be only temporary,
and further treatments may be required. As a result, viruses must
be carefully chosen and modified in an effort to optimize therapeutic effects while minimizing undesirable adverse effects. The
determination of an ideal gene transfer method remains a major
challenge for gene therapy researchers. Figure 5.1 provides a
clinical example of the potential use of gene therapy.
Current Application
One well-established, indirect form of gene therapy is called
rDNA technology. It involves the use of rDNA vectors in the
laboratory to make recombinant forms of drugs, especially biologic drugs such as hormones, vaccines, antitoxins, and monoclonal antibodies. The most common example is the use of the
Escherichia coli bacterial genome to manufacture a recombinant form of human insulin. When the human insulin gene is
inserted into the genome of bacterial cells, the resulting culture
artificially generates human insulin on a large scale. Although
CHAPTER 5 Gene Therapy and Pharmacogenomics
this insulin must be isolated and purified from its bacterial culture source, the majority of the world’s medical insulin supply
has been produced by this method for well over a decade.
Regulatory and Ethical Issues of Gene Therapy
Gene therapy research is inherently complex and can also carry
great risks for its recipients. Thus, the issue of patient safety
becomes significant. Research subjects who receive gene therapy often have a life-threatening illness, such as cancer, which
may justify the risks involved. However, case reports of deaths
in gene therapy trials have underscored these risks and raised
awareness of patient safety. The Biologics and Genetic Therapies
Directorate (BGTD) of Health Canada was assigned responsibility for oversight of gene therapy research in Canada. It reviews
clinical trials involving human gene transfer. The BGTD must
also review and approve all human clinical gene therapy trials,
as it does with any type of drug therapy.
Any institution that conducts any type of research involving
human subjects must have a research ethics board, whose purpose is to protect research subjects from unnecessary risks. An
institutional biosafety committee is also required for gene therapy
research. The role of this committee is to ensure compliance with
the Medical Council of Canada (MCC)’s Guidelines for the Handling
of Recombinant DNA Molecules and Animal Viruses and Cells.
A major ethical issue resulting from gene therapy techniques
is that of eugenics. Eugenics is the intentional selection before
birth of some genotypes that are considered more desirable
than others. For similar reasons, the prospect of being able to
manipulate genes in human germ cells (sperm and eggs) is also
a potential ethical hazard of gene therapy. Theoretically, even
cosmetic modifications could be attempted using such techniques as a part of routine family planning. Because of ethical
concerns such as these, Canadian gene therapy research is limited to somatic cells only—gene therapy in germ line (reproductive) cells is currently not approved for funding in Canada.
This limitation remains despite arguments from those who
believe that human germ cell research could potentially yield
cures for many serious chronic illnesses and disabilities, such as
Parkinson’s disease and spinal paralysis.
PHARMACOGENETICS AND
PHARMACOGENOMICS
Pharmacogenetics is a general term for the study of genetic
variations in drug response and focuses on single-gene variations. A related science that pertains more directly to the HGP
is pharmacogenomics. Pharmacogenomics is the combination of two scientific disciplines: pharmacology and genomics.
Pharmacogenomics involves how genetics (genome) affect the
body’s response to drugs. Pharmacogenomics offers physicians the opportunity to individualize drug therapy based on
a patient’s genetic makeup, rather than giving the “standard”
dose to all patients. The ultimate goal is to predict patient drug
response and proactively tailor drug selection and dosages for
optimal treatment outcomes. Warfarin sodium is an anticoagulant drug that is used to prevent blood clots (see Chapter
27). Research has shown that people with certain genetic variations (CYP2C9*2 or CYP2C9*3 alleles) are at increased risk of
71
bleeding and require lower doses than those without the variation. In addition, variations in the gene that encodes VKORC1
may make a patient more or less sensitive to warfarin sodium.
This genetic variation occurs most frequently in the Asian
population.
Individual differences in alleles that occur in at least 1% of
the population are known as genetic polymorphisms. The word
polymorphism literally means “many forms.” Polymorphisms
are considered too frequent to result from random genetic
mutations. Polymorphisms that alter the amount or actions of
drug-metabolizing enzymes can alter the body’s reactions to
medications. Known examples include those polymorphisms
that affect the metabolism of certain antimalarial drugs, the
antituberculosis drug isoniazid, and the variety of drugs that
are metabolized by several subtypes of cytochrome enzymes.
They can also alter the functioning of drug receptor proteins,
cell membrane ion channels and drug transport proteins, and
intracellular second messenger proteins (which carry out drug
actions after a drug molecule binds to a cell membrane receptor).
Differences in cytochrome enzymes (see Chapter 2) are the
best studied polymorphism effects thus far. Depending on their
existing genes for these enzymes, patients can be genetically
classified as “poor” or “rapid” metabolizers of CYP-metabolized
drugs such as warfarin sodium, phenytoin, codeine sulphate, and
quinidine. With warfarin sodium and phenytoin, a rapid metabolizer may require a higher dose of medication for the same effect,
whereas a lower dose may be best for a poor metabolizer. With
codeine sulphate, a poor metabolizer may actually need a higher
dose to get the same analgesic effect that occurs when codeine
sulphate is metabolized to morphine sulphate. In contrast, a rapid
metabolizer may convert codeine sulphate to morphine sulphate
too quickly, resulting in oversedation, and a lower dose may be
sufficient. A similar situation is also likely to occur with quinidine.
Because cytochrome enzymes are known to vary among racial
and ethnic groups, the principle of “cultural safety” becomes one
of the imperatives for routine gene-based drug dosing.
Studying both the genome of the patient and the genetics features of the pathology (e.g., tumour cells, infectious organisms)
before treatment could allow for customized drug selection and
dosing. Such analysis could permit the avoidance of drugs not
likely to be effective as well as optimization of drug doses to
minimize the risk of adverse drug effects. These applications of
pharmacogenomics are examples of personalized medicine.
DNA Microarray Technology
Most drug dosage changes are still usually made on a trial-and-error basis, by monitoring patient response. Researchers
have developed an analytical tool known as a high-density
microarray. This technology uses tiny microchip plates that
contain thousands of microscopic DNA samples. A patient’s
blood can then be screened for thousands of corresponding
DNA sequences that bind from the patient’s blood sample to
the sequences on the chip. This allows determination of the
presence or absence of various genes, such as those resulting
from drug metabolism. For example, the enzymes in the cytochrome system help metabolize from 25 to 30% of currently
available drugs. Over 40 specific cytochrome genes have been
identified thus far. The first DNA microchip for clinical use is
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PART 1 Pharmacology Basics
the AmpliChip Microarray. It is used to screen blood samples
for the individual’s cytochrome enzyme profile. Although this
type of genotypic profiling is not yet practical for widespread
use, it will eventually become a standard in clinical practice.
Table 5.1 lists several other examples of current clinical
applications of pharmacogenomics.
CASE STUDY
Genetic Counselling
During the nurse’s assessment of Darla, a newly
admitted 38-year-old patient, Darla tells the nurse,
“I’m allergic to codeine. Whenever I take it, it just
knocks me out!” She tells the nurse that codeine
does the same thing to all of her sisters.
The next day, the patient’s oncologist comes in and
explains the results of a genetic test that was performed on an outpatient basis. Darla agrees to allow the nurse to sit in on the
conversation. The oncologist tells the patient that she has a type of gene that
indicates that she has a strong chance of developing breast cancer within the
next 5 years. The oncologist recommends that she undergo a bilateral mastectomy soon to avoid the possibility of developing breast cancer and suggests
that she share this information with her sisters and her daughter, who is 18
years old. After the oncologist leaves, Darla tells the nurse, “I don’t know what
to do. I haven’t talked to one of my sisters for years and I just know she won’t
believe me. I also don’t want to worry my daughter. She is so young, and I’m
sure she’s too young to get cancer.”
1. Does Darla have an actual allergy to codeine? What else could be
happening?
2. Should the nurse tell Darla’s sister and daughter? Explain your answer.
3. What is the best way for the nurse to handle this situation?
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
APPLICATION OF GENETIC PRINCIPLES AS A
RESULT OF DRUG THERAPY AND THE NURSING
PROCESS
As noted previously, the recognition that genetic factors contribute, at some level, to most diseases continues to grow.
Thus, genetic influences on health, including the interaction of
genetic and environmental (nongenetic) factors, will routinely
affect nursing care delivery. In general, it is expected that in the
next few years genetic research will move from the laboratory to
more clinical practice settings.
Nurses in general practice settings will not be expected to
perform in-depth genetic testing or counselling. Nurses—or
other health care providers—with specialty certification in the
field of genetics will conduct genetic testing and counselling.
However, all nurses will need to have a working knowledge of
relevant genetic principles. In this era of the “new genetics”
paradigm, nurses are fully aware that nearly all diseases have a
genetic component. Conditions such as myocardial infarction,
cancer, mental health disorders, diabetes, and Alzheimer’s disease are now viewed in a different light because of the known
complex interactions between a number of factors, including
the influence of one or more genes and a variety of environmental exposures for patients.
There are several other applicable skills regarding genetics for
nurses in general practice settings. Assessment is the first step of
the nursing process, and during the assessment the nurse may
uncover factors that point to a potential for genetic disorders.
During the initial assessment, the nurse obtains a patient’s personal and family history. The family history is most effective if it
covers at least three generations and includes the current and past
health status of each family member. Assessment of factors possibly indicating an increased potential for genetic disorders is also
important. A few examples of such factors are a higher incidence
of a particular disease or disorder in the patient’s family than in
the general population; diagnosis of a disease in family members
at an unusually young age; or diagnosis of a family member with
an unusual form of cancer or with more than one type of cancer.
It is also important to inquire about any unusual reactions
to a drug on the part of the patient, family members, significant
others, and/or caregivers. An unusual or other than expected
reaction to a drug in family members may point to a difference
in the patient’s ability to metabolize certain drugs. As indicated
earlier in the chapter (as well as in Chapter 2), genetic factors
may alter a patient’s metabolism of a particular drug, resulting
in either increased or decreased drug action. Every time a medication is administered, the patient’s response to that drug must
be assessed. Any unusual medication responses in a patient may
point to a need for further investigation. Once a genetic variation is known, drug therapy may be adjusted accordingly.
As DNA chip technology becomes more affordable and accessible, it will be possible for patients to know in advance their
relative risks for different diseases in later life. Genotype testing
to identify a patient’s drug-metabolizing enzymes will help prescribers better predict a patient’s response to drug therapy.
Teaching about genetic testing and counselling may be another
responsibility of the nurse. Patients will have questions and concerns about genetic testing and other issues. Nurses in general
practice are not experts in genetic issues. However, the nurse may
help with suggestions about genetic counselling, if appropriate. If
genetic testing is ordered, the nurse may be a part of the testing
process and will need to ensure that the informed decision making and consent procedure has been carried out correctly.
Maintaining privacy and confidentiality is of utmost importance during genetic testing and counselling. The patient is the
one who decides whether to include or exclude any family members from the discussion and from knowledge of the results of
the testing. Patients need to be reminded that undergoing the
genetic test is not required and that they have the right to disclose or withhold test results from anyone. Nurses must protect against improper disclosure of information to other family
members, friends of the family, other health care providers,
and insurance providers. Nurses share the responsibility with
other health care providers to protect patients and their families
against the misuse of patients’ genetic information.
Other responsibilities of the professional nurse may include
development of clinical and social policy such as genetic nondiscrimination and prenatal testing policies, testing of genetic
products for reliability, and tasks in genetic informatics to meet
the challenge of sifting through a continually expanding body
of knowledge.
CHAPTER 5 Gene Therapy and Pharmacogenomics
TABLE 5.1
73
Clinical Applications of Pharmacogenomics
Genetic Technique
Application
Genotyping for presence of the CYP2D6 isoenzyme and
CYP2D6 alleles, determining whether patients are
poor, intermediate, extensive, or ultrarapid metabolizers resulting from these enzymes (under study)
Psychiatry and general medicine: Helps guide the prescribing of selected medications such as anticoagulants, immunosuppressants, antidepressants, antipsychotics, anticonvulsants, β-blockers, and antidysrhythmics
Genotyping for presence of the p-glycoprotein drug
transport protein (under study)
Cardiology, infectious diseases, oncology, and other practice areas: Assists in drug selection and dosing for
drugs such as digoxin, antiretrovirals, and antineoplastics
Genotyping for presence of thiopurine
methyltransferase enzyme
Oncology: Used to temper toxicity through more careful dosing of the cancer drug 6-mercaptopurine, in
children with leukemia
Genotyping for variations in β-adrenergic receptors
(under study)
Pulmonology: Determines which patients with asthma are more or less responsive to β-agonist therapy
(e.g., albuterol) and which patients might benefit from other types of drug therapy
Genotyping for presence of the Philadelphia
chromosome
Oncology: Identifies those patients with chronic myelogenous leukemia who may be stronger candidates for
the cancer drug imatinib mesylate (Gleevec®)
Genotyping for presence of the HER2/neu protooncogene
Oncology: Identifies a subset of patients with breast cancer whose tumours express this gene, which
indicates their suitability for treatment with the cancer drug trastuzumab (Herceptin®)
Viral genotyping of hepatitis C viruses
(under study)
Infectious diseases: Can determine whether a particular infection warrants 26 versus 48 weeks of drug
therapy (thereby reducing both costs and adverse drug effects)
Genotyping for the presence of factor V gene
mutation
Women’s health: Identifies women with a 7 to 100 times greater risk of thrombosis with oral contraceptive
use compared to women without the mutation
Muscle biopsy test for patients with a family history of
malignant hyperthermia
Surgery: Assesses the patient’s risk of this adverse effect known to occur with administration of various
inhalation anaesthetics and intraoperative paralyzing drugs
Genotyping for the presence of sodium channels associated with renin-angiotensin receptors and adrenal
gland receptors
Cardiology: Allows refined antihypertensive drug selection
Race-based drug selection
Cardiology: Indicates use of the drug isosorbide dinitrate/hydralazine (BiDil®) for treatment of hypertension
in patients of African descent due ultimately to genotypic variations in this patient population. This drug
is not currently available in Canada.
CYP2D6, cytochrome enzyme subtype 2D6.
SUMMARY
Increasing scientific understanding of genetic processes is
expected to revolutionize modern health care in many ways.
The artificial manipulation and transfer of genetic material,
although not a standard treatment for disease, is the focus of
over 300 human clinical gene therapy trials. The spectrum
of diseases that may eventually be treatable by gene therapy
includes inherited diseases that are present from birth, disabilities such as paralysis from spinal cord injuries, life-threatening
illnesses such as cancer, and even chronic illnesses acquired later
in life for which a person may have a genetic predisposition. The
science of pharmacogenomics has already identified some of the
genetic nuances in how different individuals’ bodies metabolize
drugs to their benefit or harm. Continued study in this area is
expected to result in proactive customization of drug therapy to
promote therapeutic benefits while minimizing or eliminating
toxic effects. Genetic procedures and therapeutic techniques
will likely become an increasing part of nursing practice as
well as health care delivery in general. As the role and impact
of genetics and genetically based drug therapy increase, so will
their role in the nursing process.
KEY POINTS
• Genetic processes are a highly complex facet of human physiology, and genetics is becoming an integral part of health
care that holds much promise in the form of new treatments
for alterations in health.
• The Human Genome Project (HGP) described in detail the
entire genome of a human individual.
• Basic genetic inheritance is carried by 23 pairs of chromosomes in each of the somatic cells; one pair of chromosomes
in each cell is called the sex chromosomes, identified as XX
for females and XY for males.
• Applicable skills for general nurses include taking thorough
patient, family, and drug histories; recognizing situations
that may warrant further investigation through genetic testing; identifying resources for patients; maintaining confidentiality and privacy; and ensuring that informed consent
is obtained for genetic testing and counselling.
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PART 1 Pharmacology Basics
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. Which is the most appropriate example of a product formed
by an indirect form of gene therapy?
a. Stem cells
b. Insulin
c. Antigen substitution
d. Platelet inhibitors or stimulators
2. The nurse is providing teaching to a client about the goal of
gene therapy. Which of the following would the nurse expect
as the result?
a. To change the patient’s own genetic functioning to treat a
given disease
b. To improve drug metabolism
c. To prevent genetic disorders in the patient’s future children
d. To stimulate the growth of stem cells
3. What is the responsibility of research ethics boards?
a. Approving all forms of human clinical gene therapy
b. Identifying all major risks to the human subjects in a specific research protocol
c. Reviewing clinical trials involving human gene
transfer
d. Analyzing genomes and determining whether they appear
mutagenic
4. The presence of certain factors in a person’s genetic makeup
that increase the likelihood of eventually developing one or
more diseases is known as
a. Genetic mutation
b. Genetic polymorphism
c. Genome predisposition
d. Genotype
5. The nurse is reviewing gene therapy. Which is a commonly
studied adenovirus?
a. Hepatitis A and C virus
b. Genovirum
c. Human influenza virus
d. Pallodium
6. Which of the following activities would be general responsibilities of a nurse working in a genetics clinic: (Select all that
apply.)
a. Assessing the patient’s personal and family history
b. Referring the patient to a genetic counsellor or other
genetic specialist
c. Communicating the results of genetic tests to the patient
and family
d. Maintaining privacy and confidentiality during the testing process
e. Answering questions about genetic test results
7. The nurse is assessing a patient for a possible increased
potential for genetic disorders. Which of these, if present,
may indicate an increased potential for a genetic disorder?
(Select all that apply.)
a. Having a brother who died of a myocardial infarction at
age 29
b. Having a family member diagnosed with more than one
type of cancer
c. Having an uncle who was diagnosed with prostate cancer
at age 73
d. A history of allergy to shellfish and iodine
e. Having a maternal grandmother, two maternal aunts, and
a sister who were diagnosed with colon cancer
CRITICAL THINKING ACTIVITIES
1. You are working on a medical–surgical unit as a newly graduated nurse. During an assessment, your patient states, “My
doctor told me that I need to have genetic testing. I just don’t
understand. If they change my genes, then it will change the
way I look!” What is the priority as you answer the patient’s
concerns?
2. An indirect form of gene therapy is already seen in contemporary health care practice. Explain this statement and provide examples.
3. Analyze the process for producing human insulin, and suggest a few theoretical examples of how this same process
could be used in other areas of health care.
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
REFERENCE
Website
•
•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
The Jackson Laboratory. (2019). Core competencies in genetics.
Retrieved from https://www.jax.org/education-and-learning/clinical-and-continuing-education/ccep-non-cancer-resources/core-competencies-for-health-care-professionals.
6
Medication Errors: Preventing
and Responding
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Compare the following terms regarding drug therapy in
the context of professional nursing practice: adverse drug
event, adverse drug reaction, allergic reaction, idiosyncratic
reaction, medical error, and medication error.
2. Describe the most commonly encountered medication errors.
3. Develop a framework for professional nursing practice for
prevention of medication errors.
4. Identify potential physical and emotional consequences of a
medication error.
5. Discuss the impact of culture and age on the occurrence of
medication errors.
6. Analyze the various ethical dilemmas concerning
professional nursing practice associated with medication
errors.
7. Identify agencies concerned with prevention of and
response to medication errors.
8. Discuss the possible consequences of medication errors
for professional nurses and other members of the health
care team.
KEY TERMS
Adverse drug event (ADE) Any undesirable occurrence
concerning administration of or failure to administer a
prescribed medication. (p. 76)
Adverse drug reactions (ADRs) Unexpected, unintended,
or excessive responses to medication given at therapeutic
dosages (as opposed to overdose); one type of adverse drug
event. (p. 76)
Allergic reaction An immunological hypersensitivity reaction
resulting from an unusual sensitivity of a patient to a
particular medication; a type of adverse drug event and a
subtype of adverse drug reactions. (p. 76)
Idiosyncratic reaction Any abnormal and unexpected
response to a medication, other than an allergic reaction,
that is peculiar to an individual patient. (p. 76)
Malpractice Improper or unethical conduct or unreasonable
lack of skill that results in harm and where compensation
GENERAL IMPACT OF ERRORS ON PATIENTS
Medical errors, and medication errors (MEs) in particular,
have received much national attention. The study that brought
medical errors to the public was the landmark study done in
1999 by the Institute of Medicine (IOM). According to this
study, the number of patient deaths from medical errors in
hospitals in the United States ranged from 44 000 to 98 000
annually, based on data from two large-scale studies. The
IOM conducted a similar study in 2006 and found that medical errors harm at least 1.5 million people per year, including
117 000 hospitalizations at a cost of over $4 billion. A follow-up study in 2010 showed 25.1 “harms” per 100 admissions
may be sought. All malpractice involves negligence.
(p. 84)
Medical errors Any errors at any point of patient care that
cause or have the potential to cause a patient harm.
(p. 75)
Medication errors (MEs) Any preventable adverse drug
events involving inappropriate medication use by a patient
or health care provider; may or may not cause the patient
harm. (p. 76)
Medication reconciliation A procedure implemented by
health care providers to maintain an accurate and up-todate list of medications for all patients between all phases of
health care delivery. (p. 82)
Negligence Unintentional harm that results from conduct that
does not meet a standard of care established by law.
(p. 84)
to the hospital. This study showed no significant change in
rates of preventable errors since the IOM study. The landmark
study of adverse events in Canadian hospitals undertaken in
2004 found that between 9 000 and 24 000 patients die each
year because of adverse events or errors. Another Canadian
study found that adverse drug–related events are responsible
for 12% of emergency department visits. Of these, 68% were
considered preventable (Zed, Abu-Laban, Balen, et al., 2008).
A more recent report found that in 2007, 17% of Canadian
adults (4.2 million) believed that a medical error had occurred
to them when receiving health care in the previous 2 years
(O’Hagan, MacKinnon, Persaud, et al., 2009). In this study,
75
76
PART 1 Pharmacology Basics
factors contributing to medical errors such as numerous prescriptions, a chronic condition, and insufficient time with the
physician were cited.
In the 2016 Canadian Institute of Health Information
report entitled Measuring Patient Harm in Canadian
Hospitals
(https://secure.cihi.ca/free_products/cihi_cpsi_
hospital_harm_en.pdf), authors found that harm in some
form, including medication incidents, occurred in 1 in every
18 hospital stays (or 138 000 hospitalizations) between 2014
and 2015 (CIHI, 2016). The three most common medication
incidents reported were with insulin (9%), hydromorphone
hydrochloride (7%), and heparin (4%). The authors also indicated that the most common contributing factor reported
(27%) was distraction or interruptions during the act of medication administration.
Numerous health institutions have made prevention of
medical errors a top priority. The most important change
to recognize is that reporting of errors should not be punitive toward the reporter. In fact, all health care providers are
encouraged to report errors. It has been shown that reporting of errors can prevent errors from occurring. Increasingly,
however, the literature reflects a shift in focus away from the
individual nurse as the source of the ME to a consideration of
the broader context. This concept has been taken a step further
and has created “just culture.” Just culture recognizes that systems are generally at fault when an error occurs, but that when
professionals do not follow policies or have repeated errors,
those professionals need remedial education and must be held
accountable. In addition to professional acknowledgement of
personal error, remediation factors including workplace culture, reporting structure, and management behaviour may
be organizational barriers to reporting (Vrbnjak, Denieffe,
O’Gorman, et al., 2016).
Medical errors can occur during all phases of health care
delivery and involve all categories of health care providers.
Some of the more common types of error include misdiagnosis, patient misidentification, lack of patient monitoring,
wrong-site surgery, and MEs. Most studies have looked at
medical errors occurring in hospitals; however, many serious MEs occur in the home. Errors occurring in homes can
be quite harmful, as potent drugs once used only in hospitals are now being prescribed for outpatients. The majority of
fatal errors at home involve the mixing of prescription drugs
with alcohol or other drugs. Intangible losses resulting from
adverse outcomes include patient dissatisfaction with, and
loss of trust in, the health care system. This loss of trust, in
turn, can lead to adverse health outcomes because patients
are afraid to seek health services. This chapter focuses on the
issues concerning MEs and ways to prevent and respond to
these errors.
MEDICATION ERRORS
An adverse drug event (ADE) is a general term that encompasses all types of clinical problems resulting from medication
use. These errors include medication errors (MEs) and adverse
drug reactions (ADRs). The various subsets of ADEs and their
s
AR
IRs
AEs
Medication errors
ADRs
Adverse drug events
Fig. 6.1 Diagram illustrating the classes and subclasses of adverse
drug events. ADRs, adverse drug reactions; AEs, adverse effects; ARs,
allergic reactions; IRs, idiosyncratic reactions.
interrelationships are illustrated in Fig. 6.1. Adverse drug reactions are reactions that occur with the use of a particular drug.
Two types of ADRs are allergic reaction (often predictable) and
idiosyncratic reaction (usually unpredictable). MEs are a common cause of adverse health care outcomes and can range from
having no significant effect to directly causing patient disability
or death.
It is important to consider all of the steps involved in the
medication use system when discussing MEs. Identifying,
responding to, and ultimately preventing MEs require an examination of the entire medication use process. Attention must
be focused on all people and all steps involved in the medication use process, including the prescriber, the transcriber
of the order, nurses, pharmacists, and any other ancillary staff
involved. A systems approach takes the Ten Rights one step further and examines the entire health care system, the health care
providers involved, and any other factor that has an impact on
the error.
Drugs commonly involved in severe MEs include central
nervous system drugs, anticoagulants, and chemotherapeutic
drugs. “High-alert” medications have been identified as those
that, because of their potentially toxic nature, require special
care when prescribing, dispensing, or administering. Highalert medications are not necessarily involved in more errors
than other drugs; however, the potential for patient harm is
higher. The Institute for Safe Medication Practices (ISMP’s)
high-alert medications are listed in Table 6.1. MEs also result
due to the large numbers of drugs with similarities in spelling or pronunciation (i.e., look-alike or sound-alike names).
Several acronyms have been created to refer to these drugs,
including SALAD (sound-alike, look-alike drugs) and LASA
(look-alike, sound-alike). Mix-ups between such drugs are
most dangerous when two drugs from different therapeutic
classes have similar names. This can result in patient effects
that are grossly different from those intended as part of the
drug therapy. For a list of examples of commonly confused
drug names, see Preventing Medication Errors: Institute for
Safe Medication Practices: Examples of Look-Alike, SoundAlike (LASA) Commonly Confused Drug Names box below.
More information on high-alert medications and SALADs can
be found on the Institute for Safe Medication Practices Canada
website at http://www.ismp-canada.org.
CHAPTER 6 Medication Errors: Preventing and Responding
TABLE 6.1
77
Examples of High-Alert Medications
Classes/Categories of Drugs
• Adrenergic agonists, IV (e.g., EPINEPHrine, phenylephrine, norepinephrine)
• Adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol)
• Anaesthetic agents, general, inhaled, and IV (e.g., propofol, ketamine)
• Antiarrhythmics, IV (e.g., lidocaine, amiodarone)
• Antithrombotic agents, including:
anticoagulants (e.g., warfarin, low-molecular-weight heparin, IV unfractionated heparin)
Factor Xa inhibitors (e.g., fondaparinux)
Direct thrombin inhibitors (e.g., argatroban, bivalirudin, dabigatran etexilate, lepirudin)
Thrombolytics (e.g., alteplase, reteplase, tenecteplase)
Glycoprotein IIb/IIIa inhibitors (e.g., eptifibatide)
• Cardioplegic solutions
• Chemotherapeutic agents, parenteral and oral
• Dextrose, hypertonic, 20% or greater
• Dialysis solutions, peritoneal and hemodialysis
• Epidural or intrathecal medications
• Hypoglycemics, oral
• Inotropic medications, IV (e.g., digoxin, milrinone)
• Insulin, subcutaneous and IV
• Liposomal forms of drugs (e.g., liposomal amphotericin B) and conventional counterparts (e.g., amphotericin B deoxycholate)
• Moderate sedation agents, IV (e.g., dexmedetomidine, midazolam)
• Moderate sedation agents, oral, for children (e.g., chloral hydrate)
• Narcotics/opioids
• IV
• Transdermal
• Oral (including liquid concentrates; immediate and sustained-release formulations)
• Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)
• Parenteral nutrition preparations
• Radiocontrast agents, IV
• Sterile water for injection, inhalation, and irrigation (excluding pour bottles) in containers of 100 mL or more
• Sodium chloride for injection, hypertonic, greater than 0.9% concentration
Specific Drugs
•
•
•
•
•
•
•
•
•
•
Epoprostenol (Flolan®), IV
Magnesium sulphate injection
Methotrexate, oral, non-oncological use
Opium tincture
Oxytocin, IV
Nitroprusside sodium for injection
Potassium chloride for injection concentrate
Potassium phosphates injection
Promethazine, IV
Vasopressin, IV or intraosseous
ISMP List of High Alert Medications in Community/Ambulatory Health Care
Classes/Categories of Medications
Specific Medications
Antiretroviral agents (e.g., efavirenz, lamiVUDine, raltegravir,
ritonavir, combination antiretroviral products)
carBAMazepine
Chemotherapeutic agents, oral (excluding hormonal agents)
(e.g., cyclophosphamide, mercaptopurine, temozolomide)
chloral hydrate liquid, for sedation of children
Antihyperglycemic drugs, oral
heparin sodium, including unfractionated and low-molecular-weight heparin
Immunosuppressant agents (e.g., azaTHIOprine, cycloSPORINE, tacrolimus)
metFORMIN
Insulin, all formulations
methotrexate, non-oncological use
Opioids, all formulations
midazolam liquid, for sedation of children
Pediatric liquid medications that require measurement
propylthiouracil
Pregnancy category X drugs (e.g., bosentan, ISOtretinoin)
warfarin sodium
Source: Institute for Safe Medication Practices (2018). ISMP List of High-Alert Medications in Acute Care Settings. Retrieved from http://www.
ismp.org/tools/institutionalhighAlert.asp; Used with permission from the Institute for Safe Medication Practices. ISMP List of High-Alert Medications in Community/Ambulatory Healthcare. Retrieved from http://www.ismp.org/communityRx/tools/highAlert-community.pdf. Used with permission from the Institute for Safe Medication Practices.
78
PART 1 Pharmacology Basics
PREVENTING MEDICATION ERRORS
Institute for Safe Medication Practices: Examples
of Look-Alike, Sound-Alike (LASA) Commonly
Confused Drug Names
Names of Medications
Comments
carboplatin vs. cisplatin
Celebrex® vs. Celexa® vs.
Cerebyx
Two different antineoplastic drugs
Anti-inflammatory drug versus antidepressant drug versus antiepileptic
drug
Vasopressor drugs of markedly different
strengths; dobutamine is also a strong
inotropic, affecting the heart
Both are injectable anaesthetics but with
a significant difference in potency and
duration of action
Short-acting versus rapid-acting insulin
Anticonvulsant/mood stabilizer versus
antifungal drug
Proton pump inhibitor versus diuretic
Antibiotic versus antidiabetic drug
Antidepressant versus antiplatelet drug
Antidepressant versus analgesic
dopamine vs. dobutamine
fentanyl vs. sufentanil
Humulin® vs. Humalog®
Lamictal® vs. Lamisil®
Losec® vs. Lasix®
metronidazole vs. metformin
Paxil® vs. Plavix®
trazodone® vs. tramadol®
The application of TALLman lettering (combinations of uppercase and lowercase letters, rather than all uppercase or all lowercase lettering) is one of several techniques and strategies to
differentiate similar drug names and optimize medication safety
during all stages of the medication-use process. TALLman lettering creates a mental alert by changing the shape of words that
look similar when seen in uppercase letters only. ISMP Canada,
the Canadian Association of Provincial Cancer Agencies, and
the International Medication Safety Network endorsed a list
of sound-alike look-alike drug names used in oncology, where
TALLman lettering is applied (e.g., VinCRIStine/VinBLAStine).
For a full list of look-alike/sound-alike drug names with recommended TALLman lettering, see http://www.ismp-canada.org.
It is widely recognized that most MEs result from weaknesses
in the systems within health care organizations rather than
from individual shortcomings. System weaknesses include failure to create a “just culture” or nonpunitive work atmosphere
for reporting errors, excessive workload with minimal time for
preventive education for staff, interruptions during medication
preparation and administration, and lack of interdisciplinary
communication and collaboration. All hospitals are required
to analyze MEs and implement ways to prevent them. Nurses
must take the time to report errors because without reporting,
no changes can be made. When errors are reported, trends can
be identified and processes can be changed to prevent the errors
from occurring again.
ISSUES CONTRIBUTING TO ERRORS
Organizational Issues
Various strategies have been used to detect and document
MEs in hospitals. MEs can occur at any step in the medication process: procuring, prescribing, transcribing, dispensing,
administering, and monitoring. Prescribing faults and prescription errors are major problems among MEs. Most prescribing
errors can be caught by the pharmacist before order entry or by
nurses prior to administration. Administration is the next most
common point in the process at which MEs occur, followed by
dispensing errors and transcription errors. It is important for
nurses to have good relationships with pharmacists, because
the two professions, working together, can have a major impact
in preventing MEs. Hospital pharmacists are usually available 24/7 and serve as great resources when the nurse has any
question regarding drug therapy. In more rural areas, having
a pharmacist or physician always available may not always be
possible or feasible. In these circumstances, it is recommended
that nurses work with the agency to develop policies and processes that outline what steps to take in the event of a potential
ME. Patient involvement in patient safety is widely advocated.
Patients who are involved and share in decision making in their
health care have better outcomes when they take on the responsibility of asking questions and seeking more information when
they need it. They learn more about their illnesses and the care
provided, and they can advocate for their own safety at each
health care encounter. Safer Healthcare Now! and the Canadian
Patient Safety Institute function to raise awareness and promote
best practices in patient safety. As part of the World Health
Organization (WHO) and Pan American Health Organization
initiative, Patients for Patient Safety Canada advocates for
patient-centred care and patient safety strategies to improve
patient safety (2012).
Effective use of technologies such as computerized prescriber
order entry and bar coding of medication packages has also been
shown to reduce MEs. In 2008, ISMP Canada and the Canadian
Patient Safety Institute sponsored a roundtable to discuss and
seek consensus on a national initiative for pharmaceutical
manufacturers concerning the use of standardized bar codes
for labelling pharmaceutical medications approved for use in
Canada. By 2012, the GS1 global Automatic Identification and
Data Capture application standard — a global bar code standard for pharmaceuticals — was adopted for Canada. In 2010,
bar code verification was being used for only 8% of institutional
beds and 33% of dispensing and compounding practices within
hospital pharmacies in Canada (Institute for Safe Medication
Practices Canada, 2013; Canadian Patient Safety Institute, 2013).
Cost is a barrier to technological improvements in general. The
cost of implementing current technology, including automated
drug dispensing cabinets with electronic charting and computerized order entry, is often prohibitive, ranging from hundreds
of thousands of dollars to millions. Nonetheless, these various
technological advances have been shown to reduce MEs. For
example, computerized order entry (also known as computerized physician order entry [CPOE]) eliminates handwriting and
standardizes many prescribing functions. Bar coding of medications allows the nurse to use electronic devices for verification of correct medication at the patient’s bedside. Computer
programs are used in the pharmacy to screen for potential drug
interactions. Despite all the benefits technology has to offer,
workload issues (i.e., nursing staff shortage), inadequate education in the use of the equipment, or difficulties in mastering
CHAPTER 6 Medication Errors: Preventing and Responding
the use of complex technology can prevent the technology from
eliminating errors as it was designed to do. Self-medication by
patients (e.g., patient-controlled analgesia) has been shown to
reduce errors, provided patients have adequate cognitive ability and mental alertness. The WHO has developed information
about patient safety concerns, safety initiatives, and patient
safety solutions (see Box 6.1).
Educational System Issues and Their Potential
Impact on Medication Errors
All health care providers have an obligation to double-check
any necessary medication information before proceeding. This
includes stopping to check medication orders and being comfortable with one’s knowledge of the drug before administering it. Numerous drug information guides are available for the
nurse’s use. Access to electronic references at the point of care
BOX 6.1 World Health Organization
Initiatives About Medications and Health
The World Health Organization (WHO) posts information on its website
regarding initiatives to promote patient safety in medication administration
and other aspects of health care. As the WHO notes, no adverse event should
ever occur, anywhere in the world, if the knowledge exists to prevent it from
happening. Knowledge is of little use, however, if it is not applied in practice.
The WHO Collaborating Centre for Patient Safety Solutions has developed
patient safety initiatives that can serve as a guide in redesigning the patient
care process to prevent the inevitable errors from ever reaching patients.
Patient safety solutions are defined by the WHO as any system design feature
or intervention that has demonstrated the ability to prevent or mitigate patient
harm arising from the health care process. Information about the first group of
patient safety solutions (2008/2009) approved by the WHO centre is available
at https://www.who.int/patientsafety/topics/solutions/en/. These patient
safety concerns include avoiding confusion of medications with look-alike,
sound-alike names; ensuring correct patient identification; enhancing communication during patient “handovers” between care units or care teams; ensuring performance of the correct procedure at the correct body site; maintaining
control of concentrated electrolyte solutions; ensuring medication accuracy
at transition points in care; avoiding catheter and tubing misconnections; and
promoting single use of injection devices and improved hand hygiene to prevent health care–associated infections.
More information about patient safety and safety initiatives is provided
in a national initiative—Safer Healthcare Now! (SHN). SHN is the flagship
program of the Canadian Patient Safety Institute (CPSI). The overarching goal
of the program is to reduce preventable injuries and deaths resulting from
adverse events. They have identified four priority areas: infection prevention and control, medication safety, surgical care, and home care. Canadian
Patient Safety Week is a national annual campaign launched by the CPSI to
raise awareness of patient safety issues common to all health care organizations. For example, the 2013 message was “Don’t hold back—Good healthcare starts with good communication.” The theme was “Ask. Listen. Talk.”
and encouraged all health care providers, patients, and their families to ASK
questions, LISTEN to the answers, and TALK openly about their concerns in
order to improve patient safety. Patients for Patient Safety Canada (2012) is a
patient-led program of the CPSI. These initiatives encourage patients to take
a role in preventing health care errors by becoming more active, involved, and
informed regarding all aspects of their health care. For more information on
these programs, visit http://www.patientsafetyinstitute.ca/ or visit https://
www.patientsafetyinstitute.ca/en/About/Programs/SHN/Pages/default.aspx.
79
are improving. Many institutions subscribe to online databases
such as Lexicomp or UpTodate that provide quick and easy
access to drug information.
Patient safety begins in the educational process, with nursing
students and faculty members. Nurses are pivotal to the medication administration process and must therefore demonstrate
safe and reliable practice. It is critically important for nurse
educators to employ teaching strategies that address a just culture of safety, one that allows students to begin their careers
with greater confidence and a healthy habit of self-monitoring.
Commonly reported student nurse errors involve the following
situations: unusual dosing times, medication administration
record issues (unavailability of the record, failure to document
doses given resulting in administration of extra doses, failure
to review the record before medicating patients), administration of discontinued or “held” medications, failure to monitor
vital signs or laboratory results, administration of oral liquids
as injections, preparation of medications for multiple patients
at the same time, and dispensing of medications in different
doses from those ordered (e.g., tablets that need to be split in
half).
Medication Errors and Related Sociological Factors
Effective communication among all members of the health care
team contributes to improved patient care. Workplace bullying among nurses is becoming an increasing issue. Bullying is
different from horizontal violence in that a real or perceived
power differential between the initiator and recipient must be
present (Einarsen, Hoel, Zapf, et al., 2011). The perpetrator’s
and target’s gender can also play a role to heighten and promote
downward bullying (McCormack, Djurkovic, Nsubuga-Kyobe,
et al., 2018). Disruptive interprofessional team behaviour and
workplace bullying, and a lack of institutional response to it,
are significant factors affecting nurse job satisfaction and nursing staff retention, as well as the erosion of personal health and
professional well-being. Disruptive behaviours can potentially
result in communication breakdown and lack of collaboration
among physicians, nurses, and other health care workers that
can lead to medical errors, adverse events, and near misses,
resulting in reduced patient care quality. It can also lead to
recruitment and retention issues, impact workers’ health and
well-being, patient safety, organization outcomes, and societal
outcomes.
Fortunately, communication between prescribers and
other members of the interprofessional health care team has
improved over the years, with newer generations of prescribers. This is due in large part to more progressive approaches
in medical education that emphasize a team orientation
and zero tolerance to any form of violence. One progressive
approach has been to include the Canadian Interprofessional
Health Collaborative (CIHC) national interprofessional core
competencies (CIHC, 2010) into health professional education and institutions (https://www.cihc.ca/files/CIHC_
IPCompetencies_Feb1210.pdf). Such approaches recognize
the ever-increasing complexities of health care delivery and
the reality that no one team member can know every fact and
provide for all patient care needs.
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PART 1 Pharmacology Basics
PREVENTING, RESPONDING TO, REPORTING,
AND DOCUMENTING MEDICATION
ERRORS: A NURSING PERSPECTIVE
Preventing Medication Errors
MEs are considered to be any preventable event that could
lead to inappropriate medication use or harm. The major categories of ME according to the Canadian Medication Incident
Reporting and Prevention System (2011) are (1) near miss
or close call where an event could result in unwanted consequences but does not, (2) no-harm event where an incident
occurs but results in no injury to the patient, (3) ME that causes
harm, and (4) critical incident resulting in serious harm. MEs
may be prevented through a variety of strategies, including the
following: (1) Multiple systems of checks and balances should
be implemented to prevent MEs. (2) Prescribers should write
legible orders that contain correct information, or orders
should be written electronically if the technology is available.
(3) Authoritative resources, such as pharmacists or current drug
literature, should be consulted if there is any area of concern,
beginning with the medication order and continuing throughout the entire medication administration process. (4) Nurses
should always check the medication order three times before
giving the drug and consult with authoritative resources (see
Chapter 3) if any questions or concerns exist. Faculty members
should not be the student’s research source regarding medications, and the safe practice of using appropriate resources should
begin early in the educational process. (5) The rights of medication administration should be used consistently; this practice
has been shown to substantially reduce the likelihood of an ME.
See Preventing Medication Errors: How to Prevent Medication
Errors box below, for a more concise and detailed listing of ways
to help prevent MEs. See Special Populations: Children box on
page 81 for a discussion of MEs in pediatric patients and special
considerations for this age group.
PREVENTING MEDICATION ERRORS
How to Prevent Medication Errors
• As the first step to defend against errors, assess information about drug allergies, vital signs, and laboratory test results.
• Use two patient identifiers before giving medications.
• Never give medications that you have not drawn up or prepared yourself.
• Minimize the use of verbal and telephone orders. If verbal or telephone orders
are used, be sure to repeat the order to confirm with the prescriber. Speak
slowly and clearly, and spell the drug name aloud.
• List the reason for use of each drug and any educational materials on the
medication administration record.
• Avoid abbreviations, medical shorthand, and acronyms because they can lead
to confusion, miscommunication, and risk of error (see Legal & Ethical Principles: Use of Abbreviations, Symbols, and Dose Designations on page 82).
• Never assume anything about a drug order or prescription, including route. If
a medication order is questioned for any reason (e.g., dose, drug, indication),
never assume that the prescriber is correct. Always be the patient’s advocate
and investigate the matter until all ambiguities are resolved.
• Do not try to decipher illegibly written orders; instead, contact the prescriber
for clarification. Illegible orders fall below applicable standards for quality medical care and endanger patient safety. If in doubt about any part of
an order, always check with the prescriber. Compare the medication order
against what is on hand by checking for the right drug, right dose, right time,
right patient, and right route.
• Never use trailing zeros (e.g., 1.0 mg) in writing and/or transcribing medication orders. Use of trailing zeros is associated with increased occurrence of
overdose. For example, “1.0 mg warfarin sodium” could be misread as “10 mg
warfarin sodium,” a 10-fold dose increase. Instead, use “1 mg” or even “one
mg.”
• Failure to use leading zeros can also lead to overdose. For example, .25 mg
digoxin could be misread as 25 mg digoxin, a dose that is 100 times the dose
ordered. Instead, write “0.25 mg.”
• Carefully read all labels for accuracy, expiration dates, dilution requirements,
and warnings.
• Remain current with new techniques of administration and new equipment.
• Encourage the use of generic names.
• Listen to and honour any concerns expressed by patients. If the patient voices
a concern about being allergic to a medication or states that a pill is not what
the patient usually takes, STOP, listen, and investigate.
• Strive to maintain your own health so you remain alert, and never be too busy
to stop, learn, and inquire. In addition, engage in ongoing continuing education.
• Become a member of professional nursing organizations to network with
other nursing students or professional nurses to advocate for improved working conditions and to stand up for the rights of nurses and patients.
• Know where to find the latest information on which dosage forms can be
or should not be crushed or opened (e.g., capsules), and educate patients
accordingly.
• Safeguard any medications that the patient had on admission or transfer so
that additional doses are not given or taken by mistake. In such situations,
safeguarding is accomplished by compiling a current medication history and
resolving any discrepancies rather than ignoring them.
• Always verify new medication administration records if they have been
rewritten or re-entered for any reason, and follow policies and procedures
about this action.
• Make sure the weight of the patient is always recorded before carrying out a
medication order, to help decrease dosage errors.
• Provide for mandatory recalculation of every drug dosage for high-risk drugs
(e.g., highly toxic drugs), or high-risk patients (e.g., pediatric or older adults)
because there is a narrow margin between therapeutic serum drug levels and
toxic levels (e.g., for chemotherapeutic drugs or digitalis drugs, or in the presence of altered liver or kidney function in a patient).
• Always suspect an error whenever an adult dosage form is dispensed for a
pediatric patient.
• Seek translators when appropriate—never guess what patients are trying to
say.
• Educate patients to take an active role in ME prevention, both in the hospital
setting and at home.
• Involve yourself politically in advocating for legislation that improves patient
safety.
SPECIAL POPULATIONS: CHILDREN
Medication Errors
Of all the ways a pediatric patient may be harmed during medical treatment, MEs
are the most common. As with older adult patients, when MEs occur, there is a
higher risk of death in children. MEs involving inpatient pediatric patients occur
frequently, estimated at a rate of 4.5 to 5.7 errors per 100 drugs used. The most
common MEs in pediatrics are dosing errors. Research has begun to identify some
of the groups of pediatric patients who are at highest risk of MEs (see Evidence in
Practice box). These include the following patients: (1) those younger than 2 years
of age, (2) those in intensive care units, specifically the neonatal intensive care
unit, (3) those in the emergency department, where there is high patient turnover
and there are diverse and unpredictable patient needs, (4) those receiving intravenous or chemotherapeutic drugs, immunosuppressive medications, lipid/total
parenteral nutrition or opioids (Maaskant, Eskes, van Rijn-Bikker, et al., 2013),
and (5) those whose weight has not been determined or recorded. The risk of harm
is compounded when a high-alert medication is involved. The top five high-alert
medications reported as causing harm or potential harm in Canadian pediatric
health care settings are morphine sulphate, potassium chloride, insulin, fentanyl,
and salbutamol (Institute for Safe Medication Practices Canada, 2009). Mathematical dosage calculations for pediatric patients are also problematic. Once the
drug has been ordered, in determination of the correct dosage, the problems of
most concern include the following: (1) inability of the nurse to understand/perform the correct calculation or dilution, (2) infrequent use of calculations, and (3)
decimal point misplacement, with potential overdosing or underdosing.
The following are some of the actions that can be taken to prevent pediatric MEs:
• Report all MEs, because this information is part of the practice of professional
nursing and helps in identifying causes of ME.
• Know the drug thoroughly, including its on- and off-label uses, action, adverse
effects, dosage ranges, routes of administration, high-alert drug status cautions (see Table 6.1), and contraindications (e.g., Is it recommended for use in
pediatric patients?).
• Confirm information about the patient each and every time a dose is given,
and check three times before giving the drug, by comparing the drug order
with the patient’s medication profile and verifying for the right drug, right
dose, right time, right route, and right patient.
• Double-check and verify information on handwritten orders that may be
incomplete, unclear, or illegible.
• Avoid verbal telephone orders in general. When they are unavoidable, always
repeat them back to the prescriber over the telephone. Insist that the prescriber sign off any emergency in-person verbal orders before leaving the unit.
• Avoid distractions while giving medications.
• Communicate with everyone (e.g., parent, caregiver) involved in patient care.
• Make sure all orders are clear and understood when patients are handed over
to other nurses with shift changes.
• Adopt standard concentrations of opioid solutions (high-alert classification)
intended for continuous intravenous infusion.
• Limit the number of concentrations and strengths of high-alert medications
available on a unit.
• Use authoritative resources such as drug handbooks, Lexicomp, Pediatric &
Neonatal Dosage Handbook, Compendium of Pharmaceuticals and Specialties,
or information from the Health Canada Drug Product Database website (http://
www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php).
EVIDENCE IN PRACTICE
Canadian Pediatric Adverse Events Study
Review
Numerous adult studies have been conducted to investigate the harm associated
with adverse events. The Canadian Adverse Effects Study conducted by Baker,
Norton and colleagues in 2004 highlighted the significance of hospital-related
harm in the adult population. This landmark study found that 7.5% of adults
admitted to hospital experience adverse events (AEs). This information provided
the foundation for improved safety of health care delivery for adults. Although
some recent epidemiological studies have contributed to the knowledge base
of pediatric safety in acute care hospitals, the scope of the problem in this vulnerable population was limited. The lack of a comprehensive pediatric trigger
tool limited the scope of the full burden of health care–associated harm. In
response to this gap, Matlow, Baker, Flintoft, and colleagues (2012) conducted
the Canadian Paediatric Adverse Events Study discussed in the following Types
of Evidence section.
Type of Evidence
This cross-sectional study used a retrospective chart review of 3 669 charts
from April 2008 to March 2009 across four age groups: 0 to 28 days; 29 days
to 1 year; older than 1 year to 5 years; and older than 5 years to 18 years).
The validated Canadian Paediatric Trigger Tool was used to identify AEs in
children admitted to 7 academic pediatric centres and 15 large community
hospitals across 7 Canadian provinces. The purpose of the study was to
determine the epidemiology (incidence and prevention) of AEs in the pediatric
population.
Results of the Study
Two hundred and thirty-seven patients (9.2%) experienced an AE resulting in
death, disability, prolonged hospital stay, or readmission. Children in the pediatric academic settings experienced more AEs (11.2%) than those in community
hospitals (3.3%). More nonpreventable AEs occurred in academic settings, while
the incidence of preventable AEs was comparable in both settings.
The reason for hospitalization and the age of the patient also influenced the occurrence of an adverse event. Neonates aged 0 to 28 days were more likely to experience
an adverse event. Neonates admitted to the intensive care unit for at least 1 day were
10 times more likely to experience an AE. Patients over the age of 28 days admitted
to surgical units were two times as likely to experience an AE as those on medical
units. Surgical errors were the most frequent overall. Children under 12 months of age
experienced more AEs from medical procedures and clinical care. Children 12 months
and older experienced more AEs from medication and diagnostic errors.
Errors in surgical units and intensive care units in academic settings were the
most common overall compared to emergency services and maternal/obstetrical
units in community settings.
Link of Evidence to Nursing Practice
These data inform health care providers that children hospitalized in health care
settings across Canada are vulnerable to harm. Children cannot advocate for
safe care, so health care providers and decision makers must be informed of the
various dangers in pediatric health care delivery. The range and burden of health
care–associated injuries established from this study is key to transformation of
the system to make health care safer.
Sources: Baker, G. R., Norton, P. G., Flintoft, V., et al. (2004). The Canadian adverse events study: The incidence of adverse events among hospital
patients in Canada. Canadian Medical Association Journal, 170(11), 1678–1686. doi:10.1503/cmaj.1040498; Canadian Patient Safety Institute.
(2013). Canadian paediatric adverse events study. Retrieved from https://www.patientsafetyinstitute.ca/en/toolsResources/ReasearcherintheRoom/
Documents/CPSI_Canadian_Paediatric_Adverse_Events_doc_March%205_2013_English_Final.pdf; Matlow, A. G., Baker, G. R., Flintoft, V., et al.
(2012). Adverse events among children in Canadian hospitals: The Canadian Paediatric Adverse Events Study. Canadian Medical Association Journal, 184(13): E709–E718. doi:10.1503/cmaj.112153
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PART 1 Pharmacology Basics
LEGAL & ETHICAL PRINCIPLES
Use of Abbreviations, Symbols, and Dose
Designations
Medication errors often occur as a result of misinterpretation of abbreviations,
symbols, and dose designations. The Institute for Safe Medication Practices
Canada, Accreditation Canada, and the Canadian Patient Safety Institute
support the elimination of dangerous abbreviations, symbols, and dose designations in health care to enhance the safety of Canadian patients and recommend that abbreviations be written out in full. As part of Accreditation Canada
Required Organizational Practices, organizations are required to identify and
implement a list of abbreviations, dose designations, and symbols that are not
to be used in the organization. This list is inclusive of the following Institute for
Safe Medication Practices Canada “Do Not Use” chart on page 84.
Note: In Canada, the trend is now toward using “mcg” in practice, so it is
important to note the difference between “mcg” and “mg” in orders.
It is the philosophy of the authors of this textbook to avoid abbreviations
whenever possible.
Source: Adapted from Institute for Safe Medication Practices (2006). List of
error-prone abbreviations, symbols, and dose designations. Retrieved from
https://www.ismp-canada.org/download/ISMPCanadaListOfDangerousAbbreviations.pdf.
In 2018, the Institute for Safe Medication Practices reaffirmed the Do Not Use;
Dangerous Abbreviations, Symbols and Dose Designations list. (https://www.
ismp-canada.org/download/safetyBulletins/2018/ISMPCSB2018-05-DoNotUseList.pdf).
Responding to, Reporting, and Documenting
Medication Errors
Responding to and reporting MEs are part of the professional
responsibilities for which nurses are accountable. If a ME does
occur, it must be reported, regardless of whether the error was
made by a nursing student or a professional nurse. Follow facility
policies and procedures for reporting and documenting the error
closely and cautiously. Once the patient has been assessed and
urgent safety issues have been addressed, report the error immediately to the appropriate prescriber and nursing management,
for example, the nurse manager or supervisor. If the patient cannot be left alone due to deterioration of the patient’s condition or
the need for close monitoring after the ME, a fellow nurse or other
qualified health care provider should remain with the patient
and provide appropriate care while the prescriber is contacted.
Follow-up procedures or tests may be ordered or an antidote prescribed. These orders should be implemented as indicated by the
prescriber. Remember that the nurse’s highest priority at all times
during the medication administration process and during a ME
is the patient’s physiological status and safety.
When a ME has occurred, complete all appropriate forms—
including an incident report—as per the facility’s policies and
procedures, and provide appropriate documentation. Document
the ME by providing only factual information about the error.
Documentation should always be accurate, thorough, and
objective. Avoid using judgemental words such as error in the
documentation. Instead, chart factual information such as the
medication that was administered, the actual dose given, and
other details regarding the order (e.g., wrong patient, wrong route,
wrong time). Also note any observed changes in the patient’s
physical and mental status. In addition, document the fact that
the prescriber was notified and any follow-up actions or orders
that were implemented. Patient monitoring should be ongoing.
Most facilities require additional documentation when an
ME occurs, consisting of an incident report or unusual occurrence report. Always follow facility policies and procedures or
protocols in completing an incident report. Documentation
should include only factual information about the error as well
as all corrective actions taken. Complete any additional sections of the form to help with the investigation of the incident.
Because these forms are forwarded to the facility’s risk management department, this complete and factual information
may help prevent errors in the future. Do not document on the
patient’s chart that an incident report was filled out, and do not
keep a copy of the incident report; incident reports are not to
be placed in the patient’s chart. The reporting of actual and suspected MEs should offer the option of anonymity. This may help
to foster improved error reporting and safe medication practices. Internal, facility-based systems of error tracking may generate data to help customize policy and procedure development.
All institutional pharmacy departments are required to have an
adverse drug event monitoring program.
Nurses as well as health care facilities may also be involved
in external reporting of MEs. There are nationwide confidential
reporting programs that collect and disseminate safety information on a larger scale. One such program is the Canadian
Medication Incident Reporting and Prevention System (https://
www.cmirps-scdpim.ca/?lang=en), which collects incident
reports of MEs. The Canada Vigilance Program is Health Canada’s
postmarket surveillance program that collects and assesses
reports of suspected adverse reactions to health products marketed in Canada. The Health Canada website (http://www.hc-sc.
gc.ca/dhp-mps/medeff/vigilance-eng.php) is a valuable source
of adverse reaction information. The Canada Vigilance Adverse
Reaction Online Database (http://www.hc-sc.gc.ca/dhp-mps/
medeff/databasdon/conditions_search-recherche-eng.php) is a
nationwide database of adverse reactions that has existed since
1965. Adverse reaction reports are submitted by health care providers and consumers on a voluntary basis, online or by telephone.
MedEffect e-Notice, provided by Health Canada, sends health
product advisories and recalls, and the Health Product InfoWatch
and MedEffect content updates are available for free by email
(http://www.hc-sc.gc.ca/dhp-mps/medeff/subscribe-abonnement/index-eng.php). ISMP Canada, Safer Heathcare Now!, and
Accreditation Canada also provide useful information to health
care providers aimed at safety enhancement.
Performing Medication Reconciliation
Communicating effectively about medications is a critical component of delivering safe care. Medication reconciliation (also
called MedRec) is a formal process in which medications are
“reconciled” at all points of entry and exit to and from a health
care entity. Medication reconciliation requires a best possible
medication history (BPMH) and entails a more systematic and
comprehensive review of all the medications a patient is taking.
The prescriber is then to assess those medications and decide if
they are to be continued upon hospitalization. Medication reconciliation was designed to ensure that there are no discrepancies between what patients were taking at home and what they
CHAPTER 6 Medication Errors: Preventing and Responding
take in the hospital. Medication reconciliation should occur at
entry into the facility, upon transfer from surgery, into or out of
the intensive care unit, and at discharge.
Although this seems to be an easy process, numerous problems have been encountered since its inception in 2005. The
first problem is that often patients do not know exactly what
medications they are taking and may report, for example, that
they take a “blue pill for blood pressure.” Sometimes the patient
may have a list of medications but some of the medications were
discontinued prior to admission, and often they fail to provide
this vital piece of information. The patient or family may not be
involved in the medication history–taking process. This can lead
to the prescriber continuing a medicine based on faulty information. System and communication factors may also impact
medication reconciliation, such as inadequate hospital policies
for medication management upon transfer and lack of systems
to verify that medications are properly documented, ordered, or
transcribed. There may also be communication issues between
physicians, about changes to medication orders or discrepancies, or poor communication between physicians and other
team members. Hospitals throughout the country are working
hard to figure out ways to avoid the problems described; this
is an ongoing process. Medication reconciliation has been part
of the Accreditation Canada program since 2006; however, due
to the problems encountered, it scaled back its requirements
in 2008 (Accreditation Canada, Canadian Institute for Health
Information, Canadian Patient Safety Institute, et al., 2012).
Medication reconciliation involves three steps:
1. Verification: Collection of the patient’s medication information with a focus on medications currently used (including
prescription drugs as well as over-the-counter medications
and natural health products)
2. Clarification: Professional review of this information to
ensure that all medications and dosages are appropriate for
the patient
3. Reconciliation: Further investigation of any discrepancies and documentation of relevant communications and
changes in medication orders
To ensure ongoing accuracy of medication use, the steps
listed below should be repeated at each stage of health care
delivery:
a. Admission
b. Status change (e.g., from critical to stable). It is the role of
the health care provider to evaluate current medications and
specify in writing which medications are to be continued or
discontinued with any status change, transfer, or discharge.
c. Patient transfer within or between facilities or health care
provider teams
d. Discharge. (The latest medication list should be provided
to the patient to take to the next health care provider, or
this information should be otherwise forwarded to the
health care provider; applicable confidentiality guidelines
should be followed.)
Following are some applicable assessment and education tips
regarding medication reconciliation:
1. Ask the patient open-ended questions and gradually move to
yes–no questions to help determine specific medication information. (Details are important and sometimes even critical.)
83
2. Avoid the use of medical jargon unless it is clear that the
patient understands and is comfortable with such language.
3. Prompt the patient to try to remember all applicable medications (e.g., patches, creams, eye drops, inhalers, professional
samples, injections, natural health products). If the patient does
provide a medication list, make a copy for the patient’s chart.
4. Clarify unclear information to the extent possible (e.g., by
talking with the home caregiver or the outpatient pharmacist
who fills the patient’s prescriptions, if needed).
5. Record the aforementioned information in the patient’s chart
as the first step in the medication reconciliation process.
6. Emphasize to the patient the importance of always maintaining a current and complete medication list and bringing it
to each health care encounter (e.g., as a wallet card or other
list). Many patients use their own computers for this. Also
encourage patients to learn the names and current dosages
of their medications.
OTHER ETHICAL ISSUES
Notification of Patients Regarding Errors
A landmark article published in the Journal of Clinical Outcomes
Management in 2001 recognized the obligation of institutions and
health care providers to provide full disclosure to patients when
errors have occurred in their care. The article not only emphasized
the ethical basis for this practice but also addressed the legal implications and was a starting point for understanding the issue of notification of patients about MEs. The Disclosure Working Group of
the Canadian Patient Safety Institute (2011) recommended a just
culture of disclosure. Apology legislation that has been introduced
in eight Canadian provinces and one territory adds a legal component to meaningful apology and disclosure of a harmful event.
The provinces and territory where this legislation exists provide
statutory protection that any apology they make to a patient cannot be used against them in subsequent court proceedings as evidence to establish fault or liability. Critical to disclosure is honesty
and transparency. Accreditation Canada includes disclosure in its
Required Organizational Practice, which includes developing a
formal, transparent organizational policy and process of disclosure
to patients. This includes support for the patient, family, and health
care worker. It is recommended that the term error be avoided
in the context of disclosure because of the complex interplay of
factors involved in patient safety incidents, as noted previously.
The working group prefers the term patient safety incident. There
are three types of patient safety incidents: (1) harmful incident
(replaces the term preventable adverse drug event) that results in
harm to the patient; (2) near miss, which did not reach the patient
and results in no harm; and, (3) no-harm incident, which reaches
the patient but no harm results. This terminology is an effort by
the World Health Organization (2016) to standardize key concepts and to improve safety worldwide. Health care organizations
offer needed financial support for reasonable expenses (e.g., travel
expenses, temporary loss of wages) in regard to the disclosure process. As well, support is recommended for health care providers
involved in the disclosure proceedings. The process of disclosure
is outlined in the document available at http://www.patientsafetyinstitute.ca/en/toolsResources/disclosure/Documents/CPSI%20
Canadian%20Disclosure%20Guidelines.pdf.
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PART 1 Pharmacology Basics
Possible Consequences of Medication
Errors for Nurses
The possible effects of MEs on patients range from no significant effect to permanent disability or even death in the most
extreme cases. However, MEs may also affect health care
providers, including nurses and student nurses, in a number
of ways. An error that involves significant patient harm or
death may take an emotional toll on the nurse involved in
the error. Nurses may be named as defendants in malpractice
litigation, with possibly serious financial consequences. In
nursing, negligence is “conduct that does not meet a standard of care established by law” (Potter, Perry, Ross-Kerr,
et al., 2014, p. 9). It is characterized chiefly by inattention
or thoughtlessness. Examples of negligent acts in nursing
include MEs that result in injury, errors in instrument counts
in surgical cases, and failure to monitor a client’s condition
adequately. Malpractice is improper or unethical conduct or
unreasonable lack of skill that results in harm, and compensation may be sought. All malpractice involves negligence.
Charges against health care workers are rare in Canada; however, as patients have become more knowledgeable about
their rights, they are more likely to seek compensation for
negligence.
Many nurses choose to carry personal malpractice insurance, also known as professional liability protection, although
nurses working in publicly funded institutional settings are
usually covered by the institution’s liability insurance policy.
Nurses should obtain clear written documentation of any
institutional coverage provided before deciding whether to
carry individual malpractice insurance. The Canadian Nurses
Protective Society (CNPS), established in 1988, is a not-forprofit society that offers legal advice, risk management services, legal assistance, and professional liability protection
concerning nursing practice to eligible nurses. These services
are available to nurses who are members in a provincial or
territorial professional organization or college (the sole exception is Quebec). Administrative responses to MEs vary from
institution to institution. One possible response is a directive to the nurse involved to obtain continuing education or
refresher training. Depending on the severity of the error,
disciplinary action, including suspension or termination of
employment, may also occur. However, hospitals have created a more proactive, open, and nonpunitive culture in the
approach to MEs. Nurses who have violated regulations of the
provincial or territorial standards of nursing practice may also
be counselled or disciplined by the provincial or territorial
regulatory bodies, which may suspend or permanently revoke
their nursing licence. Student nurses are also held responsible
and accountable for the quality of their clinical work. When in
doubt about the correct course of action, students should consult with clinical instructors or more experienced staff nurses.
If a student nurse realizes that an error has been committed,
the student should notify the responsible clinical instructor
immediately. The patient may require additional monitoring
or medication, and the prescriber may also need to be notified. Although such events are preferably avoided, they can
ultimately be useful, though stressful, learning experiences for
the student nurse.
SUMMARY
The increasing complexity of nursing practice also increases the
potential for MEs. Widely recognized and common causes of
errors include misunderstanding of abbreviations, illegibility
of prescriber handwriting, miscommunication during verbal
or telephone orders, and confusing drug nomenclature. The
structure of various organizational, educational, and sociological systems involved in health care delivery may also contribute
directly or indirectly to the occurrence of MEs. Understanding
these influences can help the nurse take proactive steps to
improve these systems. Such actions can range from fostering
improved communication with other health care team members, including students, to advocating politically for safer conditions for both patients and staff. The first priority when an
error does occur is to protect the patient from further harm,
whenever possible. All errors should serve as red flags that warrant further reflection, detailed analysis, and future preventive
actions on the part of nurses, other health care providers, and
possibly even patients themselves.
CASE STUDY
Preventing Medication Errors
During your busy clinical day as a student
nurse, the staff nurse assigned to your
patient comes to you and says, “Would
you like to give this injection? We have
a ‘now’ order for octreotide acetate 200
mcg subcutaneously. I’ve already drawn
it up; 200 mcg equals 2 mL. It needs to
be given as soon as possible, so I drew it up to save time.” She hands you a
syringe that has 2 mL of a clear fluid in it, and the patient’s medication administration record (MAR).
1. Should you give this medication “now,” as ordered? Why or why not?
You decide to check the order that is handwritten on the MAR with the order
written on the chart. The physician wrote, “Octreotide, 200 mcg now, subcut,
then 100 mcg every 8 hours as needed.” Before you have a chance to find your
instructor, the nurse returns and says, “Your instructor probably won’t let you
give the injection unless you can show the medication ampoules. Here are the
ampoules I used to draw up the octreotide. Be quick—your patient needs it
now!” You take the order, the MAR, the two ampoules, and the syringe to your
instructor. Together, you read the order and then check the ampoules. Each
ampoule is marked “Sandostatin (octreotide acetate) 500 mcg/mL.”
2. If the nurse drew up 2 mL from those two ampoules, how much octreotide
acetate is in the syringe? How does that amount compare with the order?
The nurse is astonished when you point out that the ampoules read “500
mcg/mL.” She goes into the automated medication dispenser and sees two
identical boxes of Sandostatin® next to each other in the refrigerated section.
One box is labelled “100 mcg/mL” and the other box is labelled “500 mcg/
mL.” She then realizes she chose an ampoule of the wrong strength of drug
and drew up an incorrect dose.
3. What would have happened if you had given the injection?
4. What should be done at this point? What contributed to this potential ME,
and how can it be prevented in the future?
Note: High-alert drugs include adrenal drugs (corticosteroids), analgesics
(e.g., acetaminophen), anti-infectives and antibiotics, antihistamines, antineoplastics, asthma drugs, bronchodilators, heart drugs, electrolytes, vitamins,
minerals, insulin, opioids, and sedatives.
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
CHAPTER 6 Medication Errors: Preventing and Responding
D A N G E R O U S A B B R E V I AT I O N S , SY M B O L S A N D D O S E D E S I G N AT I O N S
The abbreviations, symbols, and dose designations found in this table have been reported as being frequently
misinterpreted and involved in harmful medication errors. They should NEVER be used when communicating
medication information.
Abbreviation
Intended Meaning
Problem
Correction
U
unit
Mistaken for “0” (zero), “4” (four),
or cc.
Use “unit”.
IU
international unit
Mistaken for “IV” (intravenous) or
“10” (ten).
Use “unit”.
Misinterpreted because of similar
abbreviations for multiple drugs;
e.g., MS, MSO4 (morphine sulphate),
MgSO4 (magnesium sulphate) may
be confused for one another.
Do not abbreviate drug
names.
Abbreviations
for drug names
QD
QOD
Every day
Every other day
QD and QOD have been mistaken
for each other, or as ‘qid’. The Q has
also been misinterpreted as
“2” (two).
Use “daily” and “every
other day”.
OD
Every day
Mistaken for “right eye”
(OD = oculus dexter).
Use “daily”.
OS, OD, OU
Left eye, right eye,
both eyes
May be confused with one another.
Use “left eye”, “right eye”
or “both eyes”.
D/C
Discharge
Interpreted as “discontinue whatever
medications follow” (typically
discharge medications).
Use “discharge”.
cc
cubic centimetre
Mistaken for “u” (units).
Use “mL” or “millilitre”.
microgram
Mistaken for “mg” (milligram) resulting
Use “mcg”.
in one thousand-fold overdose.
µg
Symbol
@
>
<
Dose Designation
Trailing zero
Lack of leading
zero
Intended Meaning
Potential Problem
Correction
at
Mistaken for “2” (two) or “5” (five).
Use “at”.
Greater than
Less than
Mistaken for “7”(seven) or the
letter “L”.
Confused with each other.
Use “greater than”/”more
than” or “less than”/”lower
than”.
Intended Meaning
Potential Problem
Correction
χ.0 mg
Decimal point is overlooked resulting
in 10-fold dose error.
Never use a zero by itself
after a decimal point.
Use “χ mg”.
. χ mg
Decimal point is overlooked resulting
in 10-fold dose error.
Always use a zero before
a decimal point. Use
“0.χ mg”.
Used with permission from Institute for Safe Medication Practices (2006).
Do Not Use, Dangerous abbreviations, symbols, and dose designations,
https://www.ismp-canada.org/download/ISMPCanadaListOfDangerousAbbreviations.pdf.
Report actual and potential medication errors to ISMP Canada via the web
at https://www.ismp-canada.org/err_report.htm or by calling 1-866-54-ISMPC.
ISMP Canada guarantees confidentiality of information received and respects
the reporter’s wishes as to the level of detail included in publications.
Institute for Safe Medication
Practices Canada
Institut pour l’utilisation sécuritaire
des médicaments du Canada
Do Not Use; Dangerous Abbreviations, Symbols and Dose Designations list. Institute for Safe Medication Practices. (2018). Reaffirming the “Do Not Use: Dangerous Abbreviations, Symbols and Dose Designations” list.
(Retrieved from https://www.ismp-canada.org/download/safetyBulletins/2018/ISMPCSB2018-05-DoNotUseList.
pdf.)
85
86
PART 1 Pharmacology Basics
KEY POINTS
• To prevent MEs from misinterpretation of the prescriber’s
orders, avoid abbreviations. MEs include giving the drug
to the wrong patient, confusing sound-alike and look-alike
drugs, administering the wrong drug or the wrong dose, giving the drug by the wrong route, or giving the drug at the
wrong time.
• Measures to help prevent MEs include being prepared and
knowledgeable and taking time always to triple-check for
the right patient, drug, dosage, time, and route. It is also
important for nurses always to be aware of the entire medication administration process and to take a system analysis
approach to MEs and their prevention.
• Encourage patients to ask questions about their medications
and to question any concern about the drug or any component of the medication administration process.
• Encourage patients to always carry drug allergy information
on their persons and to keep a current list of medications
in their wallets or purses and on their refrigerators. This list
should include the drug’s name, reason the drug is being
used, usual dosage range and dosage prescribed, expected
adverse effects and possible toxicity of the drug, and the prescriber’s name and contact information.
• Report MEs. It is important to include in this documentation
the assessment of the patient status before, during, and after the
ME, as well as specific orders carried out in response to the error.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. Which measures does the nurse keep in mind to reduce the
risk of MEs?
a. When questioning a drug order, keep in mind that the
prescriber is correct.
b. Be careful about questioning the drug order a board-certified physician has written for a patient.
c. Always double-check the many drugs with sound-alike
and look-alike names because of the high risk of error.
d. If the drug route has not been specified, use the oral route.
2. During the medication administration process, it is important that the nurse remembers which guideline?
a. When in doubt about a drug, ask a colleague about it
before giving the drug.
b. Ask what the patient knows about the drug before giving
it.
c. When giving a new drug, be sure to read about it after
giving it.
d. If a patient expresses a concern about a drug, stop, listen,
and investigate the concerns.
3. If a student nurse realizes that a drug error has been made,
the instructor should remind the student of what concept?
a. The student bears no legal responsibility when giving
medications.
b. The major legal responsibility lies with the health care
institution at which the student is placed for nursing practice experience.
c. The major legal responsibility for drug errors lies with the
faculty members.
d. Once the student has committed an ME, the responsibility is to the patient and to being honest and accountable.
4. The nurse is giving medications to a newly admitted patient
who is to receive nothing by mouth (NPO status) and finds
an order written as follows: “Digoxin, 250 mcg stat.” Which
action is appropriate?
5.
6.
7.
8.
a. Give the medication immediately (stat) by mouth because
the patient has no intravenous (IV) access at this time.
b. Clarify the order with the prescribing physician before
giving the drug.
c. Ask the charge nurse what route the physician meant to
use.
d. Start an IV line and then give the medication IV so that it will
work faster, because the patient’s status is NPO at this time.
The nurse is reviewing medication orders. Which digoxin
dose is written correctly?
a. Digoxin .25 mg
b. Digoxin .250 mg
c. Digoxin 0.250 mg
d. Digoxin 0.25 mg
The nurse is administering medications. Examples of highalert medications include (Select all that apply):
a. Insulins
b. Antibiotics
c. Opiates
d. Anticoagulants
e. Potassium chloride for injection
Convert 250 micrograms to milligrams. Be sure to depict the
number correctly according to the guidelines for decimals
and zeroes.
The nurse is performing medication reconciliation during a
patient’s admission assessment. Which question by the nurse
reflects medication reconciliation?
a. “Do you have any medication allergies?”
b. “Do you have a list of all the medications, including overthe-counter, you are currently taking?”
c. “Do you need to take anything to help you to sleep at
night?”
d. “What pharmacies do you use when you fill your prescriptions?”
CHAPTER 6 Medication Errors: Preventing and Responding
87
CRITICAL THINKING ACTIVITIES
1. The health care provider has ordered a stat IV vancomycin
infusion, but when the bag comes up from the pharmacy, the
nurse notices that the dose is incorrect. It takes 2 hours for
the pharmacy to send up an IV bag with the correct dose.
While checking the medication, the nurse checks the medication rights and notes that it has been 2 hours since it was
ordered stat. What are the priority actions of the nurse, if
anything, before giving this medication?
2. Just after the nurse administers an oral antihypertensive drug,
the patient asks, “Wasn’t that supposed to be a half-tablet? I
just took the whole tablet!” The nurse realizes that the patient
was given twice the ordered amount; the order was for 25
mg, a half-tablet, and the entire 50-mg tablet was given. At
this time, what would the nurse need to say to the patient?
What are the nurse’s priority actions?
3. The nurse is reviewing the orders on a newly admitted patient
and reads this order: “Humalog insulin, 4 units daily.” What
problems, if any, would the nurse identify in this order?
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
Institute for Safe Medication Practices Canada. (2009). National collaborative: Top 5 drugs reported as causing harm through medication error in Paediatrics. ISMP Canada Safety Bulletin. Retrieved
from https://www.ismp-canada.org/download/safetyBulletins/
ISMPCSB2009-6-NationalCollaborative-Top5DrugsReported.pdf.
Institute for Safe Medication Practices Canada. (2013). Implementation planning for a medication bar code system. ISMP Canada
Safety Bulletin, 13(13), 1–6. Retrieved from http://www.ismp-canada.org/download/safetyBulletins/2013/ISMPCSB2013-13_ImplementationBarCodeSystem.pdf.
Maaskant, J. M., Eskes, A., van Rijn-Bikker, P., et al. (2013). High-alert
medications for pediatric patients: An international modified Delphi study. Expert Opinion on Drug Safety, 12(6), 805–814. https://
doi.org/10.1517/14740338.2013.825247.
McCormack, D., Djurkovic, N., Nsubuga-Kyobe, A., et al. (2018).
Workplace bullying: The interactive effects of the perpetrator’s
gender and the target’s gender. Employee Relations, 40(2), 264–280.
O’Hagan, J., MacKinnon, N. J., Persaud, D., et al. (2009). Self-reported medical errors in seven countries: Implications for Canada.
Healthcare Quarterly, 12(Spec. Iss.), 55–61.
Patients for Patient Safety Canada. (2012). Global patient safety alerts.
Sharing for learning. Retrieved from http://www.patientsforpatientsafety.ca/.
Potter, P. A., Griffin Perry, A., Ross-Kerr, J. C., et al. (2014). Canadian
fundamentals of nursing (5th ed.). Toronto, ON: Mosby Canada.
Vrbnjak, D., Denieffe, S., O’Gorman, C., et al. (2016). Barriers to
reporting medication errors and near misses among nurses: A
systematic review. International Journal of Nursing Studies, 62,
162–178. https://doi.org/10.1016/j.ijnurstu.2016.08.019.
World Health Organization. (2016). A taxonomy for patient safety.
Retrieved from http://www.who.int/patientsafety/implementation/
taxonomy/en/.
Zed, P. J., Abu-Laban, R. B., Balen, R. M., et al. (2008). Incidence,
severity and preventability of medication-related visits to the
emergency department: A prospective study. Canadian Medical
Association Journal, 178(12), 153–1569. https://doi.org/10.1503/
cmaj.071594CMAJ.
Website
•
•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
REFERENCES
Accreditation Canada, Canadian Institute for Health Information,
Canadian Patient Safety Institute. (2012). Medication reconciliation
in Canada: Raising the bar—Progress to date and the course ahead.
Ottawa, ON: Accreditation Canada. Retrieved from https://www.
ismp-canada.org/download/MedRec/20121101MedRecCanadaENG.pdf.
Canadian Institute of Health Information. (2016). Measuring patient
harm in Canadian hospitals. Retrieved from https://secure.cihi.ca/
free_products/cihi_cpsi_hospital_harm_en.pdf.
Canadian Interprofessional Health Collaborative. (2010). A national
interprofessional competency framework. Retrieved from https://
www.cihc.ca/files/CIHC_IPCompetencies_Feb1210.pdf.
Canadian Patient Safety Institute. (2013). Canadian paediatric adverse
events study. Retrieved from https://www.patientsafetyinstitute.ca/
en/toolsResources/Research/commissionedResearch/PaediatricAdverseEvents/Pages/default.aspx.
Disclosure Working Group. (2011). Canadian disclosure guidelines:
Being open and honest with patients and families. Edmonton, AB:
Patient Safety Institute. Retrieved from http://www.patientsafetyinstitute.ca/en/toolsResources/disclosure/Documents/CPSI%20
Canadian%20Disclosure%20Guidelines.pdf.
Einarsen, S., Hoel, H., Zapf, D., et al. (2011). The concept of bullying
at work: The European tradition. In S. Einarsen, H. Hoel, D. Zapf,
et al. (Eds.), Bullying and harassment in the workplace: Developments in theory, research, and practice (2nd ed.) (pp. 3–40). New
York: CRC Press.
7
Patient Education and Drug Therapy
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Discuss the importance of patient education in the safe and
efficient administration of drugs (e.g., prescription drugs,
over-the-counter drugs, natural health products).
2. Summarize the various teaching and learning principles
appropriate to patient education and drug therapy across
the lifespan, as applicable to any health care setting.
3. Identify the impact of the various developmental phases (as
described by Erikson) on patient education as it relates to
drug therapy.
4. Develop a complete patient education plan as part of a
comprehensive collaborative plan of care for drug therapy
for the adult patient.
KEY TERMS
Affective domain The most intangible domain of the learning
process. It involves affective behaviour, which is conduct
that expresses feelings, needs, beliefs, values, and opinions;
the feeling domain. (p. 89)
Cognitive domain The domain involved in the learning and
storage of basic knowledge. It is the thinking portion of
the learning process and incorporates a person’s previous
experiences and perceptions; the learning or thinking
domain. (p. 89)
Health literacy The degree to which individuals have the
capacity to obtain and then process and understand
basic health information and services needed to make
appropriate health decisions (p. 90)
Learning The acquisition of knowledge or skill that involves a
change in behaviour. (p. 89)
Psychomotor domain The domain involved in the learning of
a new procedure or skill; often called the doing domain.
(p. 89)
Teaching A system of directed and deliberate actions intended
to induce learning. (p. 89)
OVERVIEW
patients to self-manage their health behaviours. The challenge is
to develop strategies to engage patients in their own health care
(Conn, 2015).
Patient education may be one of the more satisfying aspects
of nursing care because it is essential to improved health outcomes. In fact, in the current era of increasing acuteness of
patient conditions and the need to decrease length of stays in
hospitals, patient education and family teaching become even
more essential to effectively and efficiently meet outcome criteria. Patient education has also been identified as a valued
and satisfying activity for the professional nurse as the nurse
develops a therapeutic relationship and the trust of the patient,
caregiver, and family. Nurses may often cite the lack of time and
resources to adequately teach patients; however, while there
may not always be optimum time for teaching, nurses need to
consider how they can most effectively and efficiently teach in
the time available.
Contributing to the effectiveness of patient education is an
understanding of and attention to the three domains of learning: the cognitive, affective, and psychomotor domains. It is
recommended that one or a combination of these domains be
Given the constant change in today’s health care climate and
increased consumer awareness, the role of the nurse as an
educator continues to increase and remains a significant part
of patient care, both in and out of the hospital environment.
Patient education is essential in any health care setting and is
a critical component of quality and safe health care. Patient
education is a necessary nursing practice standard that meaningfully impacts a patient’s health and quality of life. Without
patient education, the highest quality and safest care cannot be
provided. Patient education is a process, much like the nursing process; it provides patients with a framework of knowledge
that assists in the learning of healthy behaviours and assimilation of these behaviours into a lifestyle. Patient education is also
crucial for assisting patients, family, significant others, and caregivers to adapt to illness, prevent illness, maintain wellness, and
provide self-care. Being well informed provides patients with
the opportunity to be more actively involved participants and
advocates in their own health care needs. However, successful
outcomes are often dictated by the willingness and capacity of
88
CHAPTER 7 Patient Education and Drug Therapy
addressed in any patient educational session. The cognitive
domain refers to the level at which basic knowledge is learned
and stored. It is the thinking portion of the learning process and
incorporates a person’s previous experiences and perceptions.
Previous experiences with health and wellness influence the
learning of new materials, and prior knowledge and experience
can serve as the foundation for adding new concepts. Thus, the
learning process begins with identifying the experiences the
person has had with the subject matter or content. However,
it is important to remember that thinking involves more than
the delivery of new information because a patient must build
relationships between prior and new experiences to formulate
new meanings. At a higher level in the thinking process, the
new information is used to question something that is uncertain, recognize when to seek additional information, and make
decisions during real-life situations.
The affective domain is the most intangible component
of the learning process. Affective behaviour is conduct that
expresses feelings, needs, beliefs, values, and opinions. It is well
known that individuals view events from different perspectives
and often choose to internalize feelings rather than express
them. Nurses must be willing to approach patients in a nonjudgemental manner, listen to their concerns, recognize the
nonverbal messages being communicated, and assess patient
needs with an open mind. Being successful in gaining the trust
and confidence of patients and family members may have a powerful effect on their attitudes and thus on the learning process.
The psychomotor domain involves the learning of a new
procedure or skill and is often called the doing domain. Learning
is generally accomplished by demonstration of the procedure or
task using a step-by-step approach, with return demonstrations
by the learner to verify that the procedure or skill has been mastered. Using a teaching approach that engages these domains—
whether one, two, or a combination of all three—certainly adds
to the quality and effectiveness of patient education sessions and
subsequent learning.
The result of effective patient education is learning. Learning
is defined as a change in behaviour, and teaching as a sharing
of knowledge. Although you may never be certain that patients
will take medications as prescribed, you may carefully assess,
plan, implement, and evaluate the teaching you provide to help
maximize outcome criteria. Just like the nursing process, the
medication administration process and the teaching–learning
process provide systematic frameworks for professional nursing
practice. The remainder of this chapter provides a brief look at
patient education regarding drug therapy.
ASSESSMENT OF LEARNING NEEDS
REGARDING DRUG THERAPY
The patient education process is similar to the nursing process. An important facet of the patient education process is a
thorough assessment of learning needs. This assessment should
be completed before patients begin any form of drug therapy.
When considering patient education and drug therapy, a thorough assessment should include gathering subjective and objective data about the following:
89
Strategies to Enhance Patient
Education and Reduce Barriers to Learning
BOX 7.1
• Work with available educational resources in nursing and pharmacy to
collect or order and distribute materials about drug therapy. Make sure
that written materials are available to all individuals and are prepared at
a reading level that is most representative of the geographical area, such
as a Grade 8 reading level. Most acute care and other health care facilities
have electronic resources, so that printing educational materials is easy.
• Be sure that written and verbal instructions are available in the language most commonly spoken in the facility’s patient population. Identify
resources within the facility and in the community that can provide assistance with translation, such as nurses or other health care providers who
are proficient in languages other than one of the official languages. Have
the information available so that education is carried out in a timely and
effective manner.
• Perform a cultural assessment that includes questions about level of education, learning experiences, past and present successes of therapies
and medication regimens, language(s) spoken, core beliefs, value system,
meaning of health and illness, perceived cause of illness, family roles,
social organization, and health practices or lack thereof.
• Make sure that written materials are available on the most commonly used
medications and that all materials are updated annually to ensure that
information is current.
• Have available information for patients on how they can prevent medication errors. The Institute for Safe Medication Practices Canada offers informative pamphlets on the patient’s role in preventing medication errors as
well as web-based resources such as alerts for consumers with the proper
citation.
• Work collaboratively in the health care setting, inpatient and outpatient, to
develop a listing of medications that may be considered error prone, such
as cardiac drugs, chemotherapeutic drugs, low-molecular-weight heparin
sodium, digoxin, metered-dose inhaled drugs, and acetaminophen. Lack of
time for patient education is often a concern for nurses, but efforts should
be undertaken to make materials available and review these with patients
and those involved in their care. Use all available resources, such as videos,
verbal instructions, pictures, and other health care providers.
• Educate the health care consumer about the accuracy or quality of online
information and provide suggested reliable sites.
• For the adolescent, be sure to provide clear and simple directions for each
medication, including clarification of information that may well be misinterpreted. For example, adolescent girls may have the false idea that oral contraceptives prevent them from contracting sexually transmitted infections.
•
•
•
•
•
•
•
•
•
•
•
Adaptation to any illnesses
Age
arriers to learning Box 7.1)
Cognitive abilities
Coping mechanisms
Cultural background see Ethnocultural Implications
Patient Education box)
evelopmental status for age group with attention to cognitive and mental processing abilities
Education level including highest grade level completed and
literacy level
Emotional status
Environment at home and at work
olk medicine home remedies or use of alternative complementary therapies (e.g., physiotherapy, chiropractic therapy,
osteopathic medicine, meditation, yoga, aromatherapy)
90
BOX 7.2
PART 1 Pharmacology Basics
A Brief Look at Health Literacy
• According to ABC Life Literacy Canada (2018), 60% of adults and 88% of
seniors have some difficulty understanding health-related information,
which is associated with poor health outcomes (https://www.newswire.
ca/news-releases/health-literacy-still-an-issue-in-canada-694482791.
html). In regard to patient education, assessing and addressing health literacy is only one aspect, though an important aspect, of health communication and the cognitive domain of learning.
• Studies have shown that poor health literacy is associated with issues of
nonadherence to treatment regimens and disease complications, as well
as difficulty accessing health care, contributing to poor health as well as
higher health care costs (Remshardt, 2011; Roter, Rude, & Comings, 1998).
• Poor health literacy has been associated with less education, lower socioeconomic status, decrease in sensorial abilities, and multiple disease
processes, so assessment of these factors is important to individualized
patient education.
• Other areas to assess about health literacy include reading level, ability to
follow directions/instructions, as well as ability to manage everyday living
activities such as self-care, grocery shopping, and meal preparation.
• Assessment of health literacy must be done with much sensitivity and
relates not only to education but also to levels of stress or difficulty coping
with a new diagnosis or process and new and complex information (i.e.,
patients with higher levels of education but who are stressed and unable to
process information because of a disturbing diagnosis).
• evel of knowledge about any medication s being taken
• imitations physical psychological cognitive and motor
• Medications currently taken including over the counter
[OTC] drugs, prescription drugs, and natural health
products)
• Misinformation about drug therapy
• Mobility and motor skills
• Motivation
•
utritional status
• Past and present health behaviours
• Past and present experience with drug regimens and other
forms of therapy, including levels of adherence
• Race or ethnicity
• Religion or religious beliefs
• Self care ability
• Sensory status
• Social support
ETHNOCULTURAL IMPLICATIONS
Patient Education
Infancy (birth to 1 year of age): Trust versus mistrust. Infant learns to trust self,
others, and the environment; learns to love and be loved.
Toddlerhood (1 to 3 years of age): Autonomy versus shame and doubt. Toddler
learns independence; learns to master the physical environment and maintain self-esteem.
Preschool age (3 to 6 years of age): Initiative versus guilt. Preschooler learns
basic problem solving; develops conscience and sexual identity; initiates
activities as well as imitates.
School age (6 to 12 years of age): Industry versus inferiority. School-age child
learns to do things well; develops a sense of self-worth.
Adolescence (12 to 18 years of age): Identity versus role confusion. Adolescent
integrates many roles into self-identity through imitation of role models and
peer pressure.
Young adulthood (18 to 45 years of age): Intimacy versus isolation. Young
adult establishes deep and lasting relationships; learns to make commitment as spouse, parent, or partner.
Middle adulthood (45 to 65 years of age): Generativity versus stagnation. Adult
learns commitment to community and world; is productive in career, family,
and civic interests.
Older adulthood (over 65 years of age): Integrity versus despair. Older adult
appreciates life role and status; deals with loss and prepares for death.
Every health care encounter provides an opportunity to have a positive effect
on patient health. Health care providers can maximize this potential by learning more about patients’ cultures so they can respond in a respectful manner
and be responsive to the preferences of each patient, with the goal of an individualized approach to nursing care. Culture is dynamic and multidimensional
and may include gender, religion, sexual orientation, profession, values and
beliefs, age, socioeconomic status, disability, ethnicity, and race. For example,
the Indigenous peoples of Canada are a unique culture that all health care providers must understand in order to improve health care outcomes. In Canada,
the Indigenous population is made up of First Nations people, Métis, and Inuit.
The Indigenous people have experienced brutal colonization, including government-imposed policies related to land, residential schools, “Indian” hospitals,
as well as ongoing racism and discrimination. Some of this colonization also
includes the expectation to forego traditional healing practices in favour of the
Canadian medical system.
Indigenous people value their traditional healing practices and are varied
across Canada’s Indigenous groups. All elders hold an honoured position in the
Indigenous culture as most are healers and knowledgeable in traditional medicine. Elders bring experience and tradition to gatherings and usually serve as
valued teachers and leaders to guide members through healing and other spiritual ceremonies. The Indigenous peoples value the medicine wheel, a powerful symbol that honours the number four by representing the four directions,
the four seasons, and the four aspects of health. Their belief systems about
health address spiritual, mental, physical, and emotional aspects that enable
members to seek balance and harmony. The focus is on balancing life, health,
and community values.
• amily relationships
• inancial status
• Health literacy (see Box 7.2)
• Psychosocial growth and developmental level according to
Erikson’s stages (see Box 7.3)
•
ealth beliefs including beliefs about health wellness and
illness
• Information the patient understands about past and present
medical condition, medical therapy, and medications
• anguage s spoken
During the assessment of learning needs, be astutely aware
of the patient’s verbal and nonverbal communication. Often a
patient will not divulge true feelings to the nurse as the environment may not be conducive to a private conversation. Although
it might be challenging to do so, the nurse should attempt to find
a private area for the discussion. A seeming discrepancy is an
indication that the patient’s emotional or physical state may need
to be further assessed in relation to readiness and motivation for
learning. Use of open-ended questions is encouraged, because
they stimulate more discussion and greater clarification from the
BOX 7.3
Erikson’s Stages of Development
CHAPTER 7 Patient Education and Drug Therapy
patient than closed-ended questions, which require only a “yes”
or “no” answer. Ask questions about the following: (1) What do
the patient and family know about the purpose, dose, and adverse
effects of the medications? (2) Can the patient demonstrate how
the treatments are done at home?, and (3) How confident are the
patient and the family that the treatments can be carried out at
home? Assess level of anxiety, because mild levels of anxiety have
been identified as motivating, whereas moderate to severe levels
may be obstacles. In addition, if there are physical needs that are
not being met, such as relief from pain, vomiting, or other physical distress, these needs become obstacles to learning and must
be managed appropriately before any patient teaching occurs.
NURSING DIAGNOSES REGARDING LEARNING
NEEDS AND DRUG THERAPY
Some of the most commonly used nursing diagnoses regarding
patient education and drug therapy are as follows:
• Inadequate knowledge
• Readiness for enhanced knowledge
• alls potential for
• Inadequate self health management
• Readiness for enhanced health management
• Reduced memory
• In ury potential for
•
onadherence
• Readiness for enhanced communication
• Readiness for enhanced power
• Readiness for enhanced decision making
• Sleep deprivation
As an example of how nursing diagnoses regarding patient
education are derived, the nursing diagnosis of Inadequate
knowledge refers to a situation in which the patient, caregiver, or
significant other has a limited knowledge base or skills regarding the medication or medication regimen. A nursing diagnosis
of Inadequate knowledge develops out of objective or subjective
data showing that there is limited understanding, no understanding, or misunderstanding of the medication and its action,
indications, adverse reactions, toxic effects, drug–drug or drug–
food interactions, cautions, and contraindications. This diagnosis may also reflect decreased cognitive ability or reduced motor
skill needed to perform self-medication. Inadequate knowledge
differs from nonadherence; nonadherence is when the patient
does not take the medication as prescribed or at all—in other
words, the patient does not adhere with the instructions given
about the medication. Nonadherence is usually a patient’s
choice. A nursing diagnosis of nonadherence is made when data
collected from the patient show that the condition or symptoms
for which the patient is taking the medication have recurred or
were never resolved because the patient did not take the medication per the prescriber’s orders or did not take it at all. It is
critical to assess factors to determine the cause of the nonadherence (e.g., lack of ability of the patient, family, or caregiver
to administer the medication or other physical, emotional, or
socioeconomic factors). These factors are associated with the
nursing diagnosis of Inadequate health maintenance and provide a patient-centred approach to the plan of care.
91
PLANNING REGARDING LEARNING NEEDS
AND DRUG THERAPY
The planning phase of the teaching and learning process occurs
as soon as a learning need has been assessed and then identified
in the patient, family, or caregiver. With mutual understanding, the nurse and patient identify goals and outcome criteria
that are associated with the identified nursing diagnosis and
are able to relate them to the specific medication the patient is
taking. The following is an example of a measurable goal with
an outcome criterion regarding a nursing diagnosis of readiness
for enhanced knowledge for a patient who is self-administering
an oral antihyperglycemic drug and has many questions about
the medication therapy. Sample goal: The patient safely selfadministers the prescribed oral antihyperglycemic drug within
a given time frame. Sample outcome criterion: The patient
remains without signs or symptoms of overmedication while
taking an oral antihyperglycemic drug, such as hypoglycemia
with tachycardia, palpitations, diaphoresis, hunger, and fatigue.
When drug therapy goals and outcome criteria are developed,
appropriate time frames for meeting outcome criteria should
also be identified (see Chapter 1 for more information on the
nursing process). In addition, goals and outcome criteria need
to be realistic; based on patient needs; stated in patient terms;
and include behaviours that are measurable, such as list, identify, demonstrate, self-administer, state, describe, and discuss.
IMPLEMENTATION REGARDING DRUG
THERAPY
After the nurse has completed the assessment phase, identified
nursing diagnoses, and created a plan of care, the implementation phase of the teaching–learning process begins. Nurses
have a responsibility to address patients’ needs but have an
equal responsibility to teach. Providing “care” means ensuring
that patients are fully educated about their conditions and their
proposed treatments so that they are able to make informed
decisions about them. This phase includes conveying specific
information about the medication to the patient, family, or
caregiver. Teaching–learning sessions must incorporate clear,
simple, concise written instructions (Box 7.4); oral instructions;
and written pamphlets, pictures, videos, or any other learning
aids that will help ensure patient learning. The nurse may have
to conduct several brief teaching–learning sessions with multiple strategies, depending on the needs of the patient. Several
changes regarding the growth and aging of patients (although
they may also apply to other age groups experiencing chronic
diseases) may affect teaching–learning. Age-associated changes
are most pronounced in people of advanced age—85 years or
older. Table 7.1 lists educational strategies for accommodating
these changes in a plan of care. The nurse may also need to identify aids to help the patient in the safe administration of medications at home, such as the use of medication day and time
calendars, pill reminder stickers, daily medication containers
with alarms, weekly pill containers with separate compartments
for different dosing times for each day of the week, or a method
of documenting doses taken to avoid overdosage or omission of
92
BOX 7.4
Principles
PART 1 Pharmacology Basics
General Teaching and Learning
• Make learning patient-centred and individualized to each patient’s needs,
including the patient’s learning needs. This includes assessment of the
patient’s ethnocultural beliefs, educational level, previous experience with
medications, level of growth and development (to best select a teaching–
learning strategy), age, gender, family support system, resources, preferred
learning style, and level of sophistication with health care and health care
treatment.
• Assess the patient’s motivation and readiness to learn.
• Assess the patient’s ability to use and interpret label information on medication containers.
• It is estimated that 42% of Canadian adults between the ages of 16 and
65 have low literacy skills. Fifteen percent have serious problems reading printed materials and 27% have only simple reading skills. Less than
20% of individuals with the lowest literacy skills are employed (Canadian
Literacy and Learning Network, 2015). Sixty percent of immigrants have
low literacy, compared with 37% of native-born Canadians (Life Literacy
Canada, 2015). It is estimated that between 55 and 60% of adults and
88% of seniors over the age of 65 in Canada are not health literate (Public Health Agency of Canada, 2014). Indigenous people are also at risk for
poor health literacy, many of whom have less than a Grade 9 education
(Canadian Nurses Association, 2015). It is therefore important to ensure
that educational strategies and materials are at a level the patient is able
to understand, while taking care not to embarrass the patient.
• Patients who are illiterate still need to be instructed on safe medication
administration; use pictures, demonstrations, and return demonstrations to
emphasize instructions.
• Consider, assess, and appreciate language and ethnicity during patient
teaching. Make every effort to educate non–English-speaking patients in
their native languages. Ideally, the patient should be instructed by a health
provider familiar with the patient’s clinical situation who also speaks the
patient’s native language. At the least, provide the patient with detailed
written instructions in the patient’s native language.
• Assess the family support system for adequate patient teaching. Family living arrangements, financial status, resources, communication patterns, the
roles of family members, and the power and authority of different family
members should always be considered.
• Make the teaching–learning session simple, easy, fun, thorough, effective,
and not monotonous. Make it applicable to daily life, and schedule it at a
time when the patient is ready to learn. Avoid providing extraneous information that may be confusing or overwhelming to the patient.
• Remember that learning occurs best with repetition and periods of demonstration and with the use of audiovisuals and other educational aids.
• Patient teaching must focus on the various processes in the cognitive,
affective, or psychomotor domains (see earlier discussion).
• Consult online resources for help in obtaining the most up-to-date and
accurate patient teaching materials and information.
• Technology advances have increased the variety of methods available for
teaching. For example, recorded information by telephone, telephone helplines, videos, podcasts, websites, text messaging, webinars, and social
networking are some of the options for creative approaches to teaching. In
addition, there are various language translator applications, such as Google
Translate. Smartphone and tablet applications are also essential tools to
aid in patient education.
doses. Many pharmacies now package a week’s supply of pills
with a blister pack for each time of day. Medical technology
companies are developing smart technology systems to assist
patients to take and keep track of medications—for example, an
ingestible sensor that when swallowed is activated by stomach
fluids, initiating a heartbeatlike signal picked up by a patch
worn on the chest. The patch records data from the sensor, such
as that the patient has ingested the medication, and additional
information, such as heart rate. There are also patient-tracking
apps that remind patients to take their medications. Certainly,
there is a need for a large portfolio of technologies, from simple
to complex, in order to meet the needs of all patients.
Special issues arise when the patient has limited ability
to speak (or does not speak) one of the official languages of
Canada—English and rench. If at all possible the nurse should
communicate with the patient in the patient’s native language.
If the nurse is not able to communicate in the patient’s native
language, including in sign language, a translator needs to be
made available to prevent communication problems, minimize
errors, and help boost the patient’s level of trust and understanding. In practice, this translator may be another nurse or
health care provider; a nonprofessional member of the health
care team; or a layperson, family member, adult friend, or religious leader or associate. However, it is best to avoid using family members as translators if possible because of issues with bias
and misinterpretation, as well as potential confidentiality issues.
It is important to remember that some of these individuals may
not be competent in or comfortable with communicating technical clinical information, and other resources must be used
if this is the case. Canada has experienced a rapid growth in
minority populations, and our health care system has seen a
staggering increase in the percentage of non English rench
speaking patients. Demographic changes will be significant,
with the numbers of visible minority groups doubling by 2031.
This growth in cultural diversity will continue to demand that
nursing and related health care providers offer patient education materials in English rench and Southeast Asian and
East Asian languages (as well as other prominent languages).
Publications provided for non English rench speaking
patients may enable the nurse to convey a sufficient amount of
information in the patient’s language to help effectively educate
the patient and also allow the nurse to share materials with family members and caregivers for their use. Companies now also
publish a variety of patient education materials for the discharge
process in both English and rench and other languages.
on English rench speaking patients tend to notice and
appreciate their health care providers’ efforts to speak their language and will often help teach them new words or phrases, if
the nurse shows enthusiasm and interest. This experience may
lead to significantly greater rapport, put patients at ease, and
show respect for their culture or race ethnicity. btaining and
keeping available a foreign language dictionary for languages
that are widely spoken in that geographical area may be helpful. Keeping notes about newly learned words, phrases, or sentences may be helpful, too. Even if the professional does not use
the correct verb tenses, communication with the patient may
often be sufficient to meet the immediate need. As one begins
to learn a foreign language, a major challenge may be to speak
with a patient over the telephone. The important goal is to try to
increase one’s listening speed to match the speaking speed of the
patient. With effort, this can be accomplished. If one can grasp
even a few words of what the patient is saying, one may be able,
with continued conversation with the patient, to determine and
CHAPTER 7 Patient Education and Drug Therapy
TABLE 7.1
93
Strategies to Educate Older Adults With Age-Related Changes
Changes Related to Aging
Educational Strategy
Reduced Memory
Slowed cognitive functioning
Slow the pace of the presentation and attend to the patient’s verbal and nonverbal cues to verify understanding.
Decreased short-term memory
Provide smaller amounts of information at one time. Repeat information frequently. Provide written instructions for home use.
Decreased ability to think
abstractly
Use examples to illustrate information. Use a variety of methods, such as audiovisuals, props, videos, large-print materials,
materials with vivid colours, return demonstrations, and practice sessions.
Decreased ability to concentrate.
Increased reaction time (slower
to respond)
Decrease external stimuli as much as possible. Always allow sufficient time and be patient. Allow more time for feedback.
Altered Sensory Perception
Hearing
Diminished hearing
Perform a baseline hearing assessment. Use tone- and volume-controlled teaching aids; use bright, large-print material to
reinforce learning.
Decreased ability to distinguish
sounds (e.g., words beginning
with S, Z, T, D, F, and G)
Face the patient. Speak distinctly and slowly, and articulate carefully.
Decreased conduction of sound
If the learner has decreased hearing in one ear, sit on the side of the learner’s “best” ear, but always make sure the patient can
see your face as you speak.
Loss of ability to hear highfrequency sounds
Do not shout; speak in a normal voice but lower voice pitch.
Partial to complete loss of hearing
Face the patient so that lip reading is possible. Use visual aids to reinforce verbal instruction. Reinforce teaching with easyto-read materials. Provide teaching in a room with no distractions and extraneous noise. If the patient uses sign language to
communicate, find a sign language interpreter. If the patient uses a hearing aid(s), make sure the aid is/are in place and that
batteries are functioning. Use community resources for the hearing impaired.
Vision
Decreased visual acuity
Ensure that the patient’s glasses are clean and in place and that the prescription is current.
Decreased ability to read fine detail Use large-print, clear, brightly coloured material.
Decreased ability to discriminate
among blue, violet, and green:
tendency for all colours to fade,
with red fading the least
Use high-contrast materials, such as black on white. Avoid the use of blue, violet, and green in type or graphics; use red
instead.
Thickening and yellowing of the
Use nonglare lighting and avoid contrasts of light (e.g., darkened room with single light). Use additional lighting and avoid harsh
lenses of the eyes, with decreased lights, direct sunlight, and glossy paper.
accommodation
Decreased depth perception
Adjust teaching to allow for the use of touch to gauge depth.
Decreased peripheral vision
Keep all teaching materials within the patient’s visual field.
Touch and Vibration
Decreased sense of touch
Allow more time for the teaching of psychomotor skills, the number of repetitions, and the number of return demonstrations.
Decreased sense of vibration
Teach patient to palpate more prominent pulse sites (e.g., carotid and radial arteries).
Modified from Mullen, E. (2013). Health literacy challenges in the adult population. Nursing Forum, 48(4), 248–255; Speros, C. I. (2009). More than
words: Promoting health literacy in older adults. The Online Journal of Issues in Nursing, 14(3). https://doi.org/10.3912/OJIN.Vol14No03Man05
respond to the patient’s needs. However, be aware that patients
who are native English or rench speakers may also have challenges learning about their medications and treatment regimens
for other reasons—for example, learning deficits or difficulties,
hearing and speech disorders, lack of education, or minimal
previous exposure to treatment regimens and medication use.
The teaching of manual skills for specific medication administration is also part of the teaching–learning session. Sufficient
time must be allowed for the patient to become familiar with any
equipment and to perform several return demonstrations to the
nurse or another health care provider. Teaching and learning needs
will vary from patient to patient. Make every e ort to include
family members, significant others, or caregivers in the teaching
sessions for reinforcement purposes. Audiovisual aids may be
incorporated and should be based on findings from the learning
needs and nursing assessment. One online resource for information about medications is the Pharmasave medication library
(http www.pharmasave.com default medications.aspx),
which provides information for the public. Another good
resource is the Compendium of Pharmaceuticals and Specialties
94
PART 1 Pharmacology Basics
(CPS): The Canadian Drug Reference for Health Professionals,
which has an Information for the Patient component, written
in lay language, that is easier for patients to understand yet provides helpful advice and how-to information for patients on
many drugs. This section is available only in the e-CPS. This
type of resource may be helpful to the patient when seeking
information about a medication (e.g., purpose, adverse effects,
method of administration, drug interactions) and helpful to the
nurse in developing a patient teaching plan. Create a safe, nonthreatening, nondistracting environment for learning needs,
and be open and receptive to the patient’s questions. The following strategies may help ensure an effective teaching–learning
session:
• egin the teaching learning process upon the patient’s
admission to the health care setting (see the Legal & Ethical
Principles box).
• Individuali e the teaching session to the patient.
• Provide positive rewards or reinforcement for accurate return
demonstration of a procedure, technique, or skill during the
teaching session (e.g., a sticker or badge for a child).
• Complete a medication calendar that includes the names of
the drugs to be taken, along with the dosage and frequency.
Allow the patient to see what the medications look like, for
future reference.
• Use audiovisual aids.
• Involve family members or signi cant others in the teaching
session, as deemed appropriate.
• Keep the teaching on a level that is most meaningful to the
given patient; general research on reading skills has shown
that written materials must be written at a Grade 8 reading
level.
Box 7.4 lists some general teaching and learning principles to
consider in providing patient education.
Upon completion of any teaching–learning process or
patient education session, complete the documentation and
include notes about the content provided, strategies used, and
patient response to the teaching session and an overall evaluation of learning. Because of the significance of patient education
regarding drug therapy and the nursing process, this textbook
integrates patient education into each chapter in the implementation phase of the nursing process. In addition, a Patient
Teaching Tips section is included at the end of most chapters.
EVALUATION OF PATIENT LEARNING
REGARDING DRUG THERAPY
Evaluation of patient learning is a critical component of safe and
effective drug administration. To verify the success—or lack
of success—of patient education, ask specific questions about
patient outcomes and request that the patient repeat information
or give a return demonstration of skills. The patient’s behaviour,
such as adherence to the schedule for medication administration with few or no complications, is one key to determining
whether or not teaching was successful and learning occurred.
If a patient’s behaviour is characteristic of nonadherence or an
inadequate level of learning, develop, implement, and evaluate a
new plan of teaching.
LEGAL & ETHICAL PRINCIPLES
Discharge Teaching
The safest practices for discharge teaching include the following:
• Always follow the health care facility’s policy on discharge teaching, focusing on how much information to impart to the patient.
• Do not assume that any patient has received adequate teaching before
interacting with you.
• Always begin discharge teaching as soon as possible, when the patient is
ready.
• Minimize any distractions during the teaching session.
• Evaluate any teaching of the patient and significant others by having the
individuals repeat the instructions you have given them.
• Contact the institution’s social service department or the discharge planner
if there are any concerns regarding the learning capacity of the patient.
• Document what you taught, who was present with the patient during the teaching, what specific written instructions you gave, what the responses of the
patient and significant other or caregiver were, and what your nursing actions
were, such as specific demonstrations or referrals to community resources.
• Document teaching and learning strategies, such as videotapes and pamphlets.
• Case managers need to make sure patients have a follow-up phone call and
the name and number of someone to contact if they have questions, can’t
get their medication, or have symptoms.
(http://www.ahcmedia.com/articles/135610-work-with-nursing-to-makesure-patients-understand-the-discharge-plan)
Sources: Modified from the U.S. Pharmacopeia Safe Medication Use
Expert Committee Meeting, Rockville, MD, May 2003 http://www.usp.
org/; https://www.cmpa-acpm.ca/serve/docs/ela/goodpracticesguide/
pages/communication/Informed_Discharge/informed_discharge-e.html;
Okoniewska, B., Santana, M. J., Groshaus, H., et al. (2015). Barriers to
discharge in an acute care medical teaching unit: A qualitative analysis
of health providers’ perceptions. Journal of Multidisciplinary Healthcare, 8: 83–89. doi:10.2147/JMDH.S72633; https://www.ismp-canada.
org/download/MedRec/BPMDP_Patient_Interview_Guide.pdf; http://
www.nursingcenter.com/CEArticle?an=00152193-201505000-00012.
CASE STUDY
Patient Education and Anticoagulant Therapy
Martin, an 82-year-old retired civil servant, has
developed atrial fibrillation. As part of his medical
therapy, he is started on the oral anticoagulant warfarin sodium (Coumadin®). His wife reports that he
has some trouble hearing yet refuses to consider getting hearing aids. In addition, this is his first illness,
and his wife states that he has “always hated taking
medications. He’s read about herbs and folk healing
and would rather try natural therapy.” The nurse is
planning education about oral anticoagulant therapy,
and Martin says that he’ll “give it a try” for now, but
he “knows nothing about this drug.”
1. What will the nurse assess, including possible barriers to learning, before
teaching?
2. Formulate an education-related nursing diagnosis for this patient based on
the information given above. In addition, provide a goal and one example of
an outcome criterion for the nursing diagnosis.
3. What education strategies will the nurse plan to use, considering any
age-related changes the patient may have?
For answers, see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
CHAPTER 7 Patient Education and Drug Therapy
95
SUMMARY
Patient education is a critical part of patient care, and patient
education about medication administration, therapies, or regimens is no exception. rom the time of initial contact with
the patient and throughout the time the nurse works with the
patient, he or she is entitled to all information about medications prescribed as well as other aspects of patient care.
Evaluation of patient learning and adherence with the
medication regimen remain a continuous process—be willing
to listen to patients about any aspects of their drug therapy.
Professional nurses are teachers and serve as patient advocates
and thus have a responsibility to facilitate learning for patients,
families, significant others, and caregivers. Accurate assessment
of learning needs and readiness to learn always requires a look
at the whole patient, including cultural values, health practices,
and level of literacy. Every effort needs to be made to see that
the patient learns effectively to ensure successful outcomes in
regard to drug therapy—and all parts of the patient’s health care.
It is important to consult resources mentioned earlier, as well
as the Institute for Safe Medication Practices Canada ISMP
(at http www.ismp canada.org . ISMP Canada provides
nurses with a wealth of information about patient education,
safety, and prevention of medication errors. As a nonprofit organization, this institute works closely with nurses, prescribers,
regulatory agencies, and professional organizations to provide
education about medication errors and their prevention, and is
a premier resource in all matters pertaining to safe medication
practices in health care organizations.
ther resources available are medication checks. or example, in Ontario, any Ontario resident with a chronic condition and taking three or more prescription medications, or
anyone living with type 1 or type 2 diabetes, may qualify for
a MedsCheck service. Such a service provides a
to
minute, one-to-one meeting with a community pharmacist to
ensure that medications are being taken safely and appropriately. A similar program is available in New Brunswick, called
PharmaCheck.
PAT I E N T T E A C H I N G T I P S
• Teaching needs to focus on the cognitive a ective or psychomotor domain or a combination of all three. The cognitive domain may involve recall for synthesis of facts, with the
affective domain involving behaviours such as responding,
valuing, and organizing. The psychomotor domain includes
teaching someone how to perform a procedure.
• Realistic patient teaching goals and outcome criteria must be
established with the involvement of the patient, caregiver, or
significant other.
• Keep patient teaching on a level that is most meaningful to
the individual. Most research indicates that reading materials need to be written at a Grade 8 reading level but adjusted
according to patient assessment.
•
ollow teaching and learning principles when developing
and implementing patient education.
• e sure to control the environmental factors such as lighting
noise, privacy, and odours. Provide dignified care while preparing the patient for teaching, and respect personal space.
If there are distractions, such as television, radio, cellphone,
or computer, work with the patient and family members to
safely and appropriately reduce these distractions during
teaching sessions.
• Make sure that all patient education materials are organi ed
and at hand. If the patient wears glasses or hearing aids, be
sure they are made available prior to providing education.
KEY POINTS
• The e ectiveness of patient education relies on an understanding of and attention to the cognitive, affective, and psychomotor domains of learning. Once the assessment phase,
identified nursing diagnoses, and plan of care are completed,
the implementation phase of the teaching–learning process
begins; re-evaluation of the teaching plan must occur frequently and as needed. The growth in cultural diversity in
Canada, in particular the increase in the Asian and Southeast
Asian population, demands that nursing and other health
care providers make patient education materials available
not only in English and rench but also in other languages.
• Patients need to receive information through as many senses
as possible, such as aurally and visually (e.g., pamphlets, videos, diagrams), to maximize learning. Information should
also be at the patient’s reading level and in the language the
patient speaks most uently. or example a person may be
from Thailand but speaks rench and not English. Teaching
therefore would be appropriate in rench not Thai. Information should also be suitable for the patient’s level of cognitive development (see Erikson’s stages in Box 7.3).
• Teaching and learning principles also must be integrated into
patient education plans. Evaluation of patient learning is a
critical component of safe and effective drug administration.
• To verify the success—or lack of success—of patient education, nurses need to be clear and specific in their questions
about patient outcomes and request that the patient repeat
information or perform a return demonstration of skills, if
appropriate.
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PART 1 Pharmacology Basics
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. Lucas, a 47-year-old patient with diabetes, is being discharged home on insulin injections twice a day. Which
concepts should the nurse keep in mind when considering
patient teaching?
a. Teaching needs to begin at the time of diagnosis or admission and is individualized to the patient’s reading level.
b. The nurse can assume that because Lucas is in his forties
he will be able to read any written or printed documents
provided.
c. The majority of teaching can be done with pamphlets that
Lucas can share with family members.
d. A thorough and comprehensive teaching plan designed
for a Grade 11 reading level needs to be developed.
2. The nurse is developing a discharge plan regarding a patient’s
medication. Which statement about the discharge plan is
true? The teaching will:
a. Be done right before the patient leaves the hospital.
b. Be developed only after the patient is comfortable or after
pain medications are administered.
c. Include videos, demonstrations, and instructions written
at least at a Grade 5 level.
d. Be individualized and based on the patient’s level of cognitive development.
3. The nurse is responsible for preoperative teaching for a
patient who is mildly anxious about receiving narcotics postoperatively. The nurse acknowledges that this level of anxiety
may:
a. Impede learning because anxiety is always a barrier to
learning.
b. Lead to major emotional unsteadiness.
c. Result in learning by increasing the patient’s motivation
to learn.
d. Reorgani e the patient’s thoughts and lead to inadequate
potential for learning.
4. What action by the nurse is the best way to assess a patient’s
learning needs?
a. Quiz the patient daily on all medications.
b. Begin with validation of the patient’s present level of
knowledge.
c. Assess family members’ knowledge of the medication
even if they are not involved in the patient’s care.
5.
6.
7.
8.
d. Ask the caregivers what the patient knows about the medications.
Which technique would be most appropriate for teaching a
patient who does not understand English?
a. Obtain an interpreter who can speak in the patient’s native
tongue for teaching sessions.
b. Use detailed and lengthy explanations, speaking slowly
and clearly.
c. Assume that the patient understands the information presented if the patient has no questions.
d. Provide only written instructions.
A nursing student is identifying situations that involve the
psychomotor domain of learning as part of a class project.
Which are examples of learning activities that involve the
psychomotor domain? (Select all that apply.)
a. Teaching a patient how to self-administer eye drops
b. Having a patient list the adverse effects of an antihypertensive drug
c. Discussing what foods to avoid while taking antilipemic
drugs
d. Teaching a patient how to measure the pulse before taking
a beta blocker
e. Teaching a family member how to give an injection
f. Teaching a patient the rationale for checking a drug’s
blood level
The nurse is instructing an older adult patient on how to
use his walker. Which education strategies are appropriate?
(Select all that apply.)
a. Speak slowly and loudly.
b. Ensure a quiet environment for learning.
c. Repeat information frequently.
d. Allow for an increased number of return demonstrations.
e. Provide all the information in one teaching session.
You are reviewing newly prescribed medications with the
wife of a patient who will be discharged today on a liquid
diet after jaw surgery. She will be giving the patient his medications. There is a prescription for liquid metoclopramide
Reglan
mg P before breakfast lunch and dinner. The
medication is available in a strength of mg m . ow many
mL will she need to give for each dose?
CRITICAL THINKING ACTIVITIES
1. Ed, a 65-year-old patient with diabetes mellitus type 2, is
to begin treatment with insulin injections. Using the guidelines and principles for patient education discussed in this
chapter of your textbook, develop a 10-minute teaching plan
for Ed on the basics of subcutaneous self-administration of
insulin.
2. A nurse has been trying to communicate with a patient,
Narinder, who does not speak English, but so far none of the
CHAPTER 7 Patient Education and Drug Therapy
97
communication techniques has been successful. What are
the best strategies the nurse can use to develop a plan of care
that addresses Narinder’s need for medication information
on the cardiac drug digoxin and also focuses on the potential
for toxicity? (Note: You may need to look up the drug in the
textbook if you are not familiar with it.)
3. A patient has had hip replacement surgery and will be going
home in a few days. The surgeon has requested that the
nurses teach the patient and a family member how to give
subcutaneous injections of the low-molecular-weight heparin that will be prescribed for him after his discharge. What is
the priority regarding this patient’s education? Explain your
answer.
For answers, see http evolve.elsevier.com Canada illey
pharmacology .
e-LEARNING ACTIVITIES
Conn, V. S. (2015). Shifting the patient education paradigm. Western Journal of Nursing Research, 37(5), 563–565. https doi.
org .
.
Life Literacy Canada. (2015). Adult literacy facts. Retrieved from
http abclifeliteracy.ca adult literacy facts.
Public Health Agency of Canada. (2014). Health literacy. Retrieved
from http www.phac aspc.gc.ca cd mc hl ls index eng.php.
Remshardt M. A.
. The impact of patient literacy on healthcare practices. Nursing Management, 42(11), 24–29. https doi.
org .
. UMA.
.
. .
Roter . . Rude R. E. Comings .
. A barrier to quality of
care. Journal of General Internal Medicine, 13(12), 850–851. https
doi.org .
.
.
.
.x.
Website
•
•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
REFERENCES
Canadian Literacy and Learning Network. (2015). Literacy statistics.
Retrieved from http www.literacy.ca literacy literacy sub .
Canadian Nurses Association. (2015). Health literacy. Retrieved from
https www.nurseone.ca en knowledge features health literacy.
8
Over-the-Counter Drugs and Natural
Health Products
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Discuss the differences between prescription drugs, overthe-counter (OTC) drugs, and natural health products.
2. Briefly discuss the differences between the federal
legislation governing the promotion and sale of prescription
drugs and the legislation governing OTC drugs and natural
health products.
3. Describe the advantages and disadvantages of the use of
OTC drugs and natural health products.
4. Discuss the role of nonprescription drugs, specifically
natural health products and dietary supplements, in the
integrative (often called alternative or complementary)
approach to nursing and health care.
5. Discuss the potential dangers associated with the use of
OTC drugs and natural health products.
6. Develop a collaborative plan of care for the patient who uses
OTC drugs or natural health products.
KEY TERMS
Alternative medicine Herbal medicine, natural health
approaches, chiropractic, acupuncture, massage, reflexology,
and any other therapies that are not part of conventional
medicine yet are popular with many patients. (p. 102)
Cannabis Regulations Guidelines regarding access
to marihuana for medical purposes that define the
circumstances and the manner in which marihuana can be
purchased or produced. (p. 104)
Complementary medicine Alternative medicine used
simultaneously with conventional medicine. (p. 102)
Conventional medicine The practice of medicine by medical
doctors and allied health providers to treat symptoms and
diseases. Also referred to as allopathic medicine and Western
medicine. (p. 102)
Dietary supplement A product that contains an ingredient
intended to supplement the diet, including vitamins,
minerals, herbs or other botanicals, amino acids, and
substances such as enzymes, organ tissues, glandular
preparations, metabolites, extracts, and concentrates.
(p. 102)
Herbal medicine The practice of using herbs to heal. (p. 102)
Herbs Plant components including bark, roots, leaves, seeds,
flowers, fruit of trees, and extracts of these plants and
materials that are valued for their savoury, aromatic, or
medicinal qualities. (p. 102)
Homeopathy A popular form of alternative medicine that
uses microdoses of active ingredients, usually plants or
minerals, for the treatment of disease. (p. 102)
Iatrogenic effects Unintentional adverse effects caused by the
actions of a prescriber or other health care provider or by a
specific treatment. (p. 102)
Integrative medicine Simultaneous use of both conventional
and alternative medicine. (p. 102)
Natural health products (NHPs) Umbrella term for products
that includes vitamins and minerals, herbal remedies,
homeopathic medicines, traditional medicines such as
traditional Chinese medicines, probiotics, and other
products such as amino acids and essential fatty acids.
(p. 101)
Over-the-counter (OTC) drugs Medications that are legally
available without a prescription. (p. 98)
Phytochemicals The pharmacological active ingredients in
herbal remedies. (p. 104)
Phytomedicine The application of scientific research to the
practice of herbal medicine. (p. 102)
OVER-THE-COUNTER DRUGS
2009). Over 80 therapeutic classes of OTC drugs exist, marketed
to treat a variety of illnesses, including pain relievers, cold and
allergy medications, laxatives, and weight control medications.
Over the course of a year, 83% of adult Canadians take OTC
medications, 59% take multivitamins or minerals, and 27% take
herbal remedies (Ramsay, 2009). Clearly, OTC medications
comprise a large percentage of all medications used in Canada.
Health care consumers are increasingly involved in the diagnosis and treatment of common ailments. This has led to a great
increase in the use of nonprescription or over-the-counter
(OTC) drugs. There are approximately 40 000 OTC medications currently available on the Canadian market (Ramsay,
98
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
Health care consumers consider OTC drugs to be low risk and
use them to prevent, cure, or treat more than 400 different ailments. In order to reduce health care costs, many medications
that formerly required a prescription are now available OTC. It
is estimated that 40 to 87% of Canadians 65 years of age or older
use one OTC product regularly, 26% use them daily, and 5.7%
take five or more OTC or dietary supplements daily. It is also
estimated that more than 50% of children under 12 years of age
use one or more medicinal products, usually OTC drugs, in a
given week (Goldman, 2011). Some of the most commonly used
OTC products include acetaminophen (see Chapter 11), aspirin
(see Chapter 27), ibuprofen (see Chapter 49), famotidine, omeprazole and antacids (see Chapter 39), loperamide (see Chapter
40), and cough and cold products (see Chapter 37).
For nurses to understand current OTC classification, it is
helpful for them to have some knowledge of Health Canada’s
approval process for these medications. OTC drugs are regulated by the Food and Drug Regulations (see Chapter 3). The
National Drug Scheduling Advisory Committee (NDSAC) of
the National Association of Pharmacy Regulating Authorities
(NAPRA) sets out the level of professional intervention and
advice necessary for the safe and effective use of drugs by consumers. These drug schedules are based on cascading principles.
Schedule I drugs are available only by prescription. Schedule II
drugs are restricted-access drugs available only from a pharmacist and are retained in an area behind the counter where there
is no opportunity for consumer self-selection. Examples include
insulin and acetaminophen with codeine 8 mg. This strategy
ensures that the consumer is not self-medicating inappropriately and that the use of these drugs is subject to counselling by
the pharmacist. Schedule III drugs include pharmacy-only nonprescription drugs. The consumer has open access to Schedule
III drugs, and a pharmacist is available to answer questions.
Examples are antihistamines and ulcer medications. Schedule
IV drugs are those that may be prescribed by a pharmacist
according to specific guidelines. Unscheduled drugs are nonprescription drugs such as ibuprofen, acetaminophen, and nicotine gum that can be sold in any store by a nonpharmacist.
OTC drugs may also be prescribed but legally do not require a
prescription. Although OTC drugs are usually paid for by the
consumer, sometimes they are covered by public or private drug
plans.
In 2014, Health Canada launched Regulations Amending the
Food and Drug Regulations (Labelling, Packaging and Brand
Names of Drugs for Human Use), a “plain language labelling
initiative,” requiring a new, stricter “drug facts” table for OTC
products, in an easy-to-read format. The regulations include
information on the following: purpose and uses of the product,
storage information, dosage instructions, inactive ingredients,
specific warnings and adverse effects that could occur, when
the product should not be used under any circumstances, and
when it is appropriate to consult a doctor or pharmacist. This
labelling also requires information to facilitate adverse event
reporting and quality reporting, as well as evidence that drug
names would not be confused with other products. In addition,
manufacturers would be required to submit a mock-up drug
label and packaging to regulators for review. In June 2015, all
99
Fig. 8.1 Example of an over-the-counter drug label. (From US Food
and Drug Administration. [2017]. The new over-the-counter medicine
label: Take a look. Available at www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm133411.htm#.TnPoVxzZyo.email)
prescription drug products were required to adhere to the Food
and Drug Regulations regarding proper labelling of such drugs
for human use. Changes to labelling for OTC medications have
also been revised, and by June 2021, nonprescription drug labels
must adhere to these requirements (Health Canada, 2018a). See
Fig. 8.1 for an example of the standardized labelling for an OTC
drug.
Drug ingredients can also be switched from prescription to
nonprescription status. This used to involve a lengthy application process, taking 14 to 20 months from proposing a regulatory amendment to removing the ingredient from Schedule F.
Schedule F of Health Canada’s Food and Drug Regulations has
been eliminated and replaced with the Prescription Drug List
(see Chapter 3). Now, switches from prescription to nonprescription status are initiated by a request from a company in the
form of a drug submission. After reviewing these data, Health
Canada may determine that the ingredient should be available
by prescription only, or that nonprescription sale is appropriate.
Once the federal decision has been made, the provinces and territories can further restrict the conditions of sale of these products. The intent of the new process is to make nonprescription
drugs available faster. The application must contain information
and data about the safety, quality, and efficacy of the drug. The
drug usually has been marketed in Canada and other countries long enough to demonstrate that it can be used safely by
consumers on their own. Generally, to be switched from prescription to nonprescription status, a drug must meet the three
criteria listed in Box 8.1. This information is obtained from
clinical-trial results and postmarketing safety surveillance data,
which are submitted to Health Canada by the manufacturer.
OTC status has many advantages over prescription status.
Patients can conveniently and effectively self-treat many minor
ailments. Some professionals argue that allowing patients to
self-treat minor illnesses enables prescribers to spend more
time caring for patients with serious health problems. Others
argue that it delays patients from seeking medical care until they
are quite ill.
Reclassifying a prescription drug to an OTC drug may
increase out-of-pocket costs for many patients because thirdparty health insurance plans usually do not cover OTC products.
100
BOX 8.1
Status
PART 1 Pharmacology Basics
Criteria for Over-the-Counter
I. Indications for Use
Consumer must be able to easily:
• Diagnose condition
• Monitor effectiveness
Benefits of correct usage must outweigh risks.
II. Safety Profile
Drugs must have:
• Favourable adverse event profile
• Limited interaction with other drugs
• Low potential for misuse
• High therapeutic index*
III. Practicality for Over-the-Counter Use
Drugs must be:
• Easy to use
• Easy to monitor
* Ratio of toxic to therapeutic dosage.
BOX 8.2
Reclassified OTC Products
Analgesics
acetaminophen,
acetylsalicylic acid,
ibuprofen (Advil®, Motrin®)
naproxen sodium (Aleve®, Anaprox®, Naprelan®, Naproxen®)
Histamine Blockers
H1 Receptors
cetirizine (Aller-Relief®, Reactine®)
chlorpheniramine maleate (Chlor-Tripolon®)
diphenhydramine hydrochloride (Benadryl®)
loratadine (Claritin®)
Protein Pump Inhibitors
omeprazole (Prilosec®)
esomeprazole (Nexium®)
Intranasal steroids
fluticasone Propionate (Flonase®)
triamcinolone acetonide (Nasacort®)
H2 Receptors
famotidine (Pepsid®)
ranitidine (Zantac®)
Smoking Deterrents
nicotine gum (Nicorette®)
nicotine transdermal patch (Nicoderm®, Habitrol®)
Topical Medications
clotrimazole (Canesten®)
miconazole nitrate (Micazole®, Monistat®)
minoxidil (Minox®, Rogaine®)
However, overall health care costs tend to decrease when products are reclassified as OTC, due to a direct reduction in drug
costs, elimination of physician office visits, and avoidance of
pharmacy dispensing fees. Some examples of drugs that have
been reclassified as OTC products appear in Box 8.2.
The importance of patient education cannot be overemphasized. Many patients are inexperienced in interpreting medication
labels, which results in misuse of the products. This lack of experience and possibly lack of information or knowledge may lead to
adverse events or drug interactions with prescription medications,
other OTC medications, or NHPs. Small print on OTC package
labels often complicates the situation, especially for older patients.
In one study, parents gave children incorrect doses of OTC antipyretics over 50% of the time, and another 15% administered
subtherapeutic doses of acetaminophen or ibuprofen (Sullivan
& Farrar, 2011). Use of OTC medications can be hazardous for
patients with various chronic illnesses, including diabetes, liver,
kidney disease (including acute kidney injury and chronic kidney
disease), enlarged prostate, hypertension, cardiovascular disease,
and glaucoma. Patients are encouraged to read labels carefully and
consult a qualified health care provider when in doubt.
Another common problem associated with OTC drugs is
that their use may postpone effective management of serious
or life-threatening disorders. The OTC medication may relieve
symptoms without necessarily addressing the cause of the disorder. This situation is often complicated when patients are afraid to
visit a health care provider, are uninsured or underinsured, have
inadequate health literacy (see Chapter 7), lack access to a family
physician or clinic, or perhaps wish to avoid visiting a health care
provider and hope for a “quick fix” for themselves or their children.
OTC medications also have their own toxicity profiles. For
example, cough and cold products usually include one or more
of the following ingredients: nasal decongestants (for stuffy nose),
expectorants (for loosening chest mucus), antihistamines (for
sneezing and runny nose), and antitussives (for cough). In 2008,
Health Canada issued recommendations that OTC cough and
cold medicines (CCMs) not be used in children younger than 6
years of age. This action followed numerous case reports of symptoms such as oversedation, seizures, tachycardia, and even death
in toddlers medicated with such products. There is also evidence
that such medications are simply not efficacious in young children.
Numerous studies have shown a dramatic decrease in visits of
young children to emergency departments since the recommendation (Hampton, Nguyen, Edwards, et al., 2013; Shehab, Schaefer,
Kegler, et al., 2010). Health Canada continues to evaluate the safety
and efficacy of cough and cold products for children but has issued
no guidelines to date. Parents are advised to be mindful of how
much medication they give to their children and to be careful not
to give two products that contain the same active ingredient(s).
Two other examples of OTC drug dangers include products containing acetaminophen (e.g., Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (e.g.,
Advil®, Motrin®), naproxen (e.g., Aleve®). Hepatic toxicity is
associated with excessive doses of acetaminophen and is a leading cause of liver failure. Acetaminophen doses are not to exceed
a total of 4 grams (4 000 mg) per day for patients with normal
liver function (this dosage was reviewed and recommended by
Health Canada in 2016; see Chapter 11 for more detail). The use
of NSAIDs is associated with gastrointestinal ulceration, myocardial infarction, and stroke. Patients may sometimes choose
excessive dosages of these and other OTC medications out of
lack of knowledge or simply in hopes of easing their symptoms.
Health Canada finalized regulations requiring specific labelling
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
for acetaminophen (in 2009) and aspirin (in 2013) to enhance
consumer awareness of these risks. The most current guidance
document for NSAIDs is from 2006. In addition, Johnson and
Johnson, the manufacturers of Tylenol in Canada, developed
a website with specific information for consumers on dosages, adverse effects, drug interactions and related information
(http://www.tylenol.ca/adult-pain-relief).
Misuse can also be a potential hazard with the use of OTC
drug products. Pseudoephedrine is found in a variety of cough
and cold products (see Chapter 37); however, this drug is also
used to manufacture the widely misused street drug, methamphetamine. Because of the potential for misuse, products
containing pseudoephedrine must be sold from behind the
pharmacy counter. Many patients become addicted to OTC
nasal sprays because they can cause rebound congestion and
dependency. Dextromethorphan (used as a cough suppressant) is also commonly misused. It is known by the brand name
Robitussin, and misusing it is called Robotripping.
Several other OTC products can cause specific problems.
The use of sympathomimetics (e.g., epinephrine, pseudoepinephrine; see Chapter 19) can cause adverse effects in patients
with type 1 diabetes (elevated plasma glucose levels), hypertension, or angina (e.g., dysrhythmias). Aspirin is not to be used in
children as it can cause a rare condition called Reye’s syndrome
(see Chapter 27). Long-term use of antacids can result in constipation or impaction (see Chapter 39).
Normally, OTC medications should be used for only shortterm treatment of common minor illnesses. An appropriate
medical evaluation is recommended for all chronic health conditions, even if the final decision is to prescribe OTC medications. Patient assessment includes questions on OTC drug use,
including on what conditions are being treated. Such questions
may help uncover more serious ongoing medical problems.
Inform patients that OTC drugs, including NHPs, are still
TABLE 8.1
101
medications. Their use may have associated risks, depending on
the specific OTC drugs or NHPs used, concurrent prescription
medications, and the patient’s overall health status and disease
state.
Health care providers have an excellent opportunity to prevent common problems associated with the use of OTC drugs.
Up to 60% of patients consult a health care provider when selecting an OTC product. Provide patients with information about
choice of an appropriate product, correct dosing, common
adverse effects, and drug interactions with other medications.
For specific information on OTC drugs, see the appropriate
drug chapters later in this text (see Table 8.1 for a cross-reference to these chapters).
NATURAL HEALTH PRODUCTS
History
In Canada, natural health products are subject to the Food and
Drugs Act and Food and Drug Regulations. Internationally, the
regulation of natural health products varies. There are many
differences in how countries approach the regulation of health
products. In Canada, as in European Union countries, natural
health products are considered drugs, whereas in the United
States, many natural health products are classified as “dietary
supplements.” Under the Natural Health Products Regulations,
natural health products (NHPs) is the umbrella term that
includes vitamin and mineral supplements; herbal remedies;
homeopathic preparations; traditional Chinese, Ayurvedic, and
other traditional medicines; probiotics; and other products such
as amino acids and essential fatty acids (Health Canada, 2018b).
The language surrounding NHPs can be confusing. For
example, in the United States, dietary supplements are considered to be food products. In Canada, they were considered
NHPs and were regulated as such. However, in 2013, Health
Common OTC Drugs Discussed in This Book
Type of OTC Drug
Example
Where Discussed in This Book
Acid-controlling drugs (H2
blockers, proton pump
inhibitors) and antacids
famotidine (Pepsid AC®), omeprazole (heart burn control®), ranitidine
hydrochloride (Zantac®); aluminum- and magnesium-containing products
(Maalox®, Mylanta®), calcium-containing products (Tums®)
Chapter 39: Acid-Controlling Drugs
Antifungal drugs (topical)
clotrimazole (Canesten®), miconazole nitrate (Micozole®, Monistat®)
Chapter 56: Dermatological Drugs
Antihistamines and
decongestants
brompheniramine maleate (Dimetane®, Dimetapp®)
cetirizine hydrochloride (Reactine®)
chlorpheniramine maleate (Advil Cold and Sinus®, Chlor-Tripolon®, Triaminic®)
diphenhydramine hydrochloride (Benadryl, Nadryl®)
fexofenadine hydrochloride (Allerga®)
guaifenesin (Balminil®)
loratadine (Claritin®)
desloratidine (Aerius®, Allernix), pseudoephedrine hydrochloride (Actifed®)
Chapter 37: Antihistamines, Decongestants, Antitussives, and Expectorants
Eye drops
Artificial tears (Murine®)
Chapter 57: Ophthalmic Drugs
Hair growth drugs (topical)
minoxidil (Rogaine®)
Chapter 56: Dermatological Drugs
Pain-relieving drugs (analgesics)
acetaminophen (Tylenol®)
Chapter 11: Analgesic Drugs
Pain-relieving drugs (NSAIDs)
aspirin
ibuprofen (Advil®, Motrin®)
naproxen sodium (Aleve®, Naprelan®)
Chapter 49: Anti-Inflammatory and Antigout Drugs
102
PART 1 Pharmacology Basics
Canada announced that it would transition products that more
appropriately fit the definition of a food away from the Natural
Health Products Regulations. To clarify the differences in language and terminology, a brief discussion of the forms and
history of various NHPs follows. Basic definitions are provided
here to ensure complete understanding and to prevent confusion in how these terms are used.
Dietary supplement is a broad term for orally administered
alternative medicines and includes the category of herbal supplements. Although there are differences in what is considered
a dietary supplement, they are products intended to augment
the diet and include ingredients such as vitamins, minerals,
herbs or other botanicals, amino acids, dietary substances that
supplement the diet by increasing the total dietary intake, concentrates, metabolites, constituents, or extracts (Health Canada,
2012). Dietary supplements are produced in many forms, such
as tablets, capsules, softgels, gelcaps, liquids, and powders. These
supplements may also be found in nutritional, breakfast, snack,
or health food bars; drinks; and shakes.
Herbs come from nature and include the leaves, bark, berries, roots, gums, seeds, stems, and flowers of plants. They have
been used for thousands of years to help maintain good health.
Herbs have been an integral part of society because of their culinary and medicinal properties. About 30% of all modern drugs
are derived from plants (Table 8.2). In Canada, Indigenous peoples have been using sacred herbs and the medicine wheel (see
Chapter 4) for centuries. Herbs, including tobacco, sage, cedar,
and sweetgrass, are used by First Nations, Métis, and Inuit populations. Both sacred herbs and the medicine wheel are important elements to support Indigenous people and their families to
embrace all four health aspects of Indigenous culture (spiritual,
mental, physical, and emotional).
In the early nineteenth century, scientific methods became
more advanced, and the development and mass production
of chemically synthesized drugs revolutionized health care
in most parts of the world. During this time, the practice of
botanical healing was dismissed as quackery. Nonetheless,
herbal medicines (or the practice of phytomedicine) are
now in great demand in the developing world for primary
health care because they are inexpensive and have better cultural acceptability, are reasonably safe and effective, and have
TABLE 8.2
From Plants
Conventional Medicines Derived
Medicine*
Plant
atropine
capsaicin
cocaine
codeine
digoxin
paclitaxel
quinine
scopolamine
senna
vincristine
Atropa belladonna
Capsicum frutescens
Erythroxylon coca
Papaver somniferum
Digitalis purpurea
Taxis brevifolia
Cinchona officinalis
Datura fastuosa
Cassia acutifolia
Catharanthus roseus
*Includes both OTC and prescription drugs
advantageous compatibility and minimal adverse effects (World
Health Organization, 2015). However, use of traditional medicine is not limited to developing countries, and during the past
two decades, public interest in natural therapies has increased
greatly in industrialized countries, with expanding use of ethnobotanicals. Indeed, in the future, traditional herbal medicine
research may play a critical role in global health.
Herbs and plants can be processed and ingested in numerous
ways and forms. This includes whole herbs, teas, essential oils,
ointments, salves, syrup, tinctures, rubs, capsules, and tablets
that contain a ground or powdered form of a raw herb or its
dried extract. Plant and herb extracts vary in the solvent used
for extraction, temperature, and extraction time and include
alcoholic extracts (tinctures), vinegars (acetic acid extracts),
hot water extracts (tisanes), long-term boiled extracts, usually
roots or bark (decoctions), and cold infusion of plants (macerates). There is no standardization, and components of an herbal
extract or a product are likely to vary significantly between
batches and producers (Benzie & Wachtel-Galor, 2011). Herbs
are generally to be taken intermittently, not in continuous daily
dosing.
In the 1960s, concerns were expressed over the iatrogenic
effects of (medicine taught in the West). These concerns, along
with a desire for more self-reliance, led to a renewed interest
in “natural health,” and as a result, the use of NHPs, including the use of herbal products, increased. In 1974, the World
Health Organization (WHO) encouraged developing countries to use traditional plant medicines. In 1978, the German
equivalent of Health Canada published a series of herbal recommendations known as the Commission E Monographs. These
monographs focus on herbs whose effectiveness for specific
indications is supported by the research literature. Recognition
of the rising use of herbal medicines and other nontraditional
remedies, known as alternative medicine, led to the establishment of the Office of Alternative Medicine by the National
Institutes of Health, in 1992. This office was later renamed the
National Center for Complementary and Alternative Medicine
(NCCAM), and in 2014, it was again renamed, now to the
National Center for Complementary and Integrative Health
(NCCIH). Complementary medicine refers to the simultaneous use of both conventional and alternative medicine. This
practice is also referred to as integrative medicine. NCCIH
classifies complementary health approaches into three categories: 1) natural products, 2) mind and body practices, and 3)
other complementary health approaches. A popular form of
alternative medicine is homeopathy. Homeopathy is based on
the belief that a disease can be treated by the administration of
a microdose of a substance thought to cause the physical signs
of that disease. Homeopathy is thought to stimulate the body’s
immune defences.
Many controversies remain about the safety and the control
of NHPs, although they continue to be used in Canada and
abroad. Their uses and touted advantages are widely publicized.
As a result, these products are marketed and placed in grocery
stores, pharmacies, health food stores, and fitness gyms and can
even be ordered through television and radio ads and over the
internet. Adverse effects are considered minimal by the public
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
as well as by the companies and businesses that sell these supplements. However, this belief has created a false sense of security because the public’s view tends to be that if a product is
“natural” then it is safe. The information provided in this book
regarding NHPs does not imply author or publisher endorsement of such products.
Concerns over the accessibility and regulation of all NHPs
led the Health Canada Directorate to establish the Advisory
Panel on Natural Health in 1997. After consultations with interested stakeholders, the Minister of Health tabled Natural Health
Products: A New Vision, which provided the framework for the
development of the Office of Natural Health Products. This
office would later be renamed the Natural and Non-prescription
Health Products Directorate (NNHPD). In 2004, the Natural
Health Products Regulations came into effect. Manufacturers
must obtain a product licence from Health Canada to sell their
products in Canada. If the product meets the NNHPD criteria, then a Natural Product Number (NPN) will be issued. The
Licensed Natural Health Products Database (LNHPD), managed by Health Canada, provides information on licensed NHPs.
These include vitamin and mineral supplements, herb- and
plant-based remedies, traditional medicines (e.g., traditional
Chinese medicines or Ayurvedic [Indian] medicines), omega-3
and essential fatty acids, probiotics, homeopathic medicines,
and numerous consumer products, such as certain toothpastes,
antiperspirants, shampoos, facial products, and mouthwashes.
This database can be accessed at http://www.hc-sc.gc.ca/dhpmps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.
php.
Homeopathic medicines (HMs) receive a Drug Identification
Number (DIN)-HM, followed by a product number. Extensive
product labelling must meet specific requirements regarded as
essential to risk management. Based on information from the
WHO, the European Scientific Cooperative on Phytotherapy,
and the German Commission E, the NNHPD developed the
Compendium of Monographs. The regulations also impose
standard labelling requirements to ensure that consumers can
make informed choices about NHPs. Labels contain such details
as the product name, the quantity of the product in the container, and the recommended conditions for use, which include
recommended use or purpose and dose, warnings, cautionary
statements, contraindications, and possible adverse reactions.
With such regulations, Canada, similar to Germany, France,
and the United Kingdom, enforces standards for the assessment
of natural-product quality and safety.
Consumer Use of Natural Health Products
Consumer use of NHPs is growing. In 2016, approximately 79%
of Canadians used an alternative therapy during their lifetime
(Fraser Institute, 2017). An estimated 73% of Canadians use
some form of alternative medicine and regularly take NHPs,
such as vitamins and minerals, herbal products, and homeopathic medicines (Health Canada, 2015), even though 12% who
use them experience adverse reactions and only 41% who experience adverse effects report them. Canadians who take NHPs
and prescription drugs are six times as likely to suffer unwanted
adverse effects as those who use only drugs (Necyk, Barnes,
103
Tsuyuki, et al., 2013). Consumers select NHPs for the treatment
and prevention of diseases and, proactively, to preserve health
and wellness and boost the immune system (e.g., to reduce
cardiovascular risk factors, increase liver and immune system
functions, increase feelings of wellness). In addition, herbs may
be used as adjunct therapy to support conventional pharmaceutical therapies.
Some products may be used to treat minor conditions and
illnesses (e.g., coughs, colds, stomach upset) in much the same
manner as conventional Health-Canada–approved OTC nonprescription drugs are used. As the number of NHPs on the
market increases, nurses will need to respond to patient educational needs about these products.
Safety
NHPs, particularly herbal medicines, are often perceived as
natural and therefore healthier than conventional drugs; however, this is not always the case. There are examples of allergic reactions, toxic reactions, and adverse effects caused by
herbs. Some herbs have been shown to have possible mutagenic effects and to interact with drugs (see Natural Health
Products: Selected Natural Health Products and their Possible
Drug Interactions box). It is thought that many patients using
NHPs do not disclose this to their health care providers.
Patients are reluctant to disclose use for fear of disapproval
by their health care providers, that they will not give their full
attention to the topic, and because typically most health care
providers have limited understanding of NHPs (Walji, Boon,
Barnes, et al., 2010; Barry, 2018). In addition, there are concerns about the level of consumer knowledge of these products and their risks, even among regular users. These factors
demonstrate the need for health care providers to develop a
clinical knowledge base regarding these products and know
where to find key information as the need arises. Because of
under-reporting, present knowledge may represent but a small
fraction of potential safety concerns.
There are few published scientific data regarding the
safety of NHPs. Two recent examples indicating some of
the growing concerns with specific herbal remedies include
Health Canada warnings about possible liver toxicity with
the use of kava root and possible cardiovascular and stroke
risks with the use of ephedra. Ephedra remains on the market
and in 2012, after a 10-year ban, Health Canada regulated
kava root as a new drug. Also, many herbal products are best
avoided in patients with cardiovascular diseases as there is
risk for drug interactions and possible contamination or substitution with other medications, and there is no evidence to
support any clinical improvement with use (Tachjian, Vigar,
& Jahanjir, 2010; Liperoti, Vetrano, Bernabei, et al., 2017).
Herbal products can increase bleeding risk with warfarin
sodium (see Chapter 26), potentiate digoxin toxicity (see
Chapter 25), increase the effects of antihypertensive agents
(see Chapter 23), and cause heart block or dysrhythmias (see
Chapter 26).
In order to improve the NHP vigilance system, Health
Canada has put in place several initiatives that are available
to both consumers and health care providers. The Canada
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PART 1 Pharmacology Basics
NATURAL HEALTH PRODUCTS
Selected Natural Health Products and Their Possible Drug Interactions
Natural Health Product
Possible Drug Interaction
Chamomile
Cranberry
Echinacea
Evening primrose
Garlic
Ginkgo biloba
Increased potential for bleeding with anticoagulants
Decreased elimination of many drugs excreted by the kidneys
Possible interference with or counteraction to immunosuppressant drugs and antivirals
Possible interaction with antipsychotic drugs
Possible interference with hypoglycemic therapy and the anticoagulant warfarin sodium (Coumadin®)
May increase risk of bleeding with use of anticoagulants (warfarin sodium, heparin sodium) and antiplatelets (aspirin,
clopidrogrel)
At high dosages, possible interference with cardiac, antidiabetic, or anticoagulant drugs
Decreases metabolism of drugs used for erectile dysfunction
Decreases metabolism of estrogens and some psychotherapeutic drugs (benzodiazepines, sertraline)
Increases risk of toxicity of immunosuppressants, HMG-CoA reductase inhibitors, and of some psychotherapeutic drugs
(pimozide, escitalopram)
Increases intensity and duration of effects of caffeine
May lead to toxic levels of cardiac glycosides (e.g., digitalis)
May increase the effect of barbiturates and alcohol
May change the effects of hormones in oral contraceptive drugs, patches, or hormonal replacement therapies
May lead to serotonin syndrome if used with other serotonergic drugs (e.g., selective serotonin reuptake inhibitors [see
Chapter 17])
Strong CYP 3A4 inducer, resulting in decreased concentrations of many drugs
Increases central nervous system depression if used with sedatives
Ginger root
Grapefruit
Hawthorn
Kava
Saw palmetto
St. John’s wort
Valerian
Modified from Bailey, D. G., Dresser, G., & Arnold, J. M. O. (2013). Grapefruit–medication interactions: Forbidden fruit or avoidable consequences?
Canadian Medical Association Journal, 185(4). doi: 10.1503/cmaj.120951; Seden, K., Dickinson, L., Khoo, S., et al. (2010). Grapefruit-drug interactions. Drugs, 70(18): 2373–2407.
Vigilance Program is Health Canada’s postmarket surveillance program that maintains an online database of suspected adverse reactions submitted by both consumers and
health care providers. The database provides information
only. Through the MedEffect program, consumers and health
care providers can report adverse effects from NHPs via web,
phone, fax, or mail. Also available is the Health Product Info
Watch, published monthly, with health product advisories and
summary safety information about marketed health products
and information on new health product safety. Other authoritative references that can be utilized for herbal information
include Pharmacist’s Letter, Prescriber’s Letter, and Natural
Medicines (formerly Natural Medicines Comprehensive
Database and Natural Standard), all available at http://www.
naturalstandard.com/. Health care providers need to be on the
alert for announcements about the safe and effective use of
NHPs as well as their reported adverse effects. The discriminating and proper use of some products may provide some
therapeutic benefits, but the indiscriminate or excessive use
of NHP supplements can be dangerous (see Ethnocultural
Implications box).
Level of Use
There are approximately 16 000 NHPs currently licensed for
use in Canada, with many new products introduced annually.
A great deal of public interest in the use of NHPs remains.
Estimates of the prevalence of use differ greatly.
The many different herbs in these preparations contain a
wide variety of active phytochemicals (plant compounds).
Herbal medicine is based on the premise that plants contain
natural substances that can promote health and alleviate illness.
Some of the more common ailments and conditions treated
with herbs are anxiety, arthritis, colds, constipation, cough,
depression, fever, headache, infection, insomnia, intestinal disorders, premenstrual syndrome, menopausal symptoms, stress,
ulcers, and weakness.
NHPs constitute the largest growth area in retail pharmacy,
and their use is increasing, exceeding the growth in the use
of conventional drugs. Some of the most commonly used
natural health herbal remedies are aloe, black cohosh, chamomile, echinacea, feverfew, garlic, ginger, Ginkgo biloba, ginseng, goldenseal, hawthorn, St. John’s wort, saw palmetto, and
valerian.
Medical Use of Marihuana
Marihuana is an herb with a long history of use for its therapeutic and medicinal qualities. On October 17, 2018, cannabis and related products including marihuana became
legal in Canada and are regulated under the Cannabis Act
and Cannabis Regulations. Both the Cannabis Act and
Cannabis Regulations replaced the Access to Cannabis for
Medical Purposes Regulations (ACMPR). In 2003, prior to
legalization, Health Canada implemented the Marihuana
Medical Access Regulations (MMAR) to allow access to and
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
possession of marihuana for individuals suffering from specific grave and debilitating illnesses, while protecting public safety. These regulations were repealed in 2014, and the
Marihuana for Medical Purposes Regulations (MMPRs)
came into effect. In 2015, the Supreme Court of Canada
ruled against the federal government to expand the definition of medical marihuana beyond the “dried” form and
allow the consumption of medical marihuana as well as use
other extracts and derivatives (Do, 2015).
Individuals who use marihuana for medical reasons can
access marihuana for medical purposes after registering with
the federal government. Once authorized by their health care
provider, patients can access medical marihuana by purchasing direct from a seller licensed by the federal government,
registering with Health Canada in order to produce a prescribed amount of cannabis in their home, or by appointing
an agent or designate to produce cannabis on their behalf
(Government of Canada, 2018). See Box 8.3 for discussion of
the use of marihuana (also known as cannabis) for medical
purposes.
NURSING PROCESS
ASSESSMENT
Over-the-Counter Drugs
Nursing assessments are always important to perform, but they
are especially important in situations in which the patient is
self-medicating. Reading level, cognitive level, motor abilities,
previous use of OTC drugs, successes versus failures with drug
therapies and self-medication, and caregiver support are just
a few of the variables to be assessed, as deemed appropriate.
Other assessment data include questioning about allergies to
any of the drug’s ingredients or additives (e.g., dyes, preservatives, or fillers). Include a list of all medications and substances
used by the patient in the medication history, including OTC
drugs, prescription drugs, herbal products, vitamins, and minerals. Also note use of alcohol, tobacco, and caffeine. Assess
past and present medical history so that possible drug interactions, contraindications, and cautions are identified. Screen
patients carefully before recommending an OTC drug because
patients often assume that if a drug is sold OTC it is completely
safe to take and without potential negative consequences. This
is not true—OTC drugs can be just as lethal or problematic as
prescription drugs if they are not taken properly or are taken in
high dosages and without regard to directions (see discussion
earlier in the chapter).
Assessment of the patient’s knowledge about the components of self-medication, including the positive and negative consequences of the use of a given OTC drug, must be
included. Assessment of the patient’s (or caregiver’s or family member’s) level of knowledge and experience with OTC
self-medication is critical to the patient’s safety, as is assessment of attitudes toward and beliefs about their use. This is
especially true if a casual attitude is combined with a lack of
knowledge, which could result in overuse, overdosage, and
105
ETHNOCULTURAL IMPLICATIONS
Drug Responses and Ethnocultural Factors
Responses to drugs, including OTC drugs and NHPs, may be affected by
beliefs, values, and genetics as well as by culture, race, and ethnicity. As one
example of the impact of culture on drug response and use, if patients who are
Japanese experience nausea, vomiting, or bowel changes as adverse effects
of OTC drugs or NHPs, these often are not mentioned. The reason is that individuals in this culture find it unacceptable to report gastrointestinal symptoms
and they may remain unreported to the point of causing risk to the patient.
NHPs, specifically herbal and alternative therapies, may also be used more
extensively in some cultures than in others. Wide acceptance of herbal use
without major concern for the effects on other therapies may be problematic
because of the many interactions of conventional drugs with herbs and dietary
supplements. For example, the Chinese herb ginseng may inhibit or accelerate the metabolism of a specific medication and significantly affect the drug’s
absorption or elimination.
One genetic factor that has an influence on drug response is acetylation
polymorphism; that is, prescription drugs, OTC drugs, and NHPs may be metabolized in different ways that are genetically determined and vary with race or
ethnicity. For example, populations of European or African descent contain
approximately equal numbers of individuals showing rapid and slow acetylation (which affects drug metabolism), whereas Japanese and Inuit populations
may contain more rapid acetylators. See Chapter 4 for a more in-depth discussion of these specific genetic attributes.
Source: Modified from Munoz, C., & Hilgenberg, C. (2005). Ethnopharmacology, Am J Nurs 105(8):40–49.
potential complications. See Chapter 7 for more information
on patient education.
For the most part, laboratory tests are not ordered before
the use of OTC drugs because these drugs are self-administered and self-monitored. However, there are situations in
which patients may be taking certain medications that react
adversely with OTC drugs, and laboratory testing may be
needed. Some patient groups are also at higher potential for
adverse reactions to OTC drugs (as to most drugs in general), including pediatric and older adult patients; patients
with single and/or multiple acute and chronic illnesses; those
who are frail or in poor health, debilitated and whose diets are
nutritionally inadequate; and those with suppressed immune
systems. OTC drugs must also be used with caution and may
be contraindicated in patients with a history of kidney, liver,
heart, or vascular dysfunction. More assessment information
for OTC drugs and NHPs can be found in other chapters in
this textbook, where relevant (see Table 8.1 on page 101). It
is important to remember that consumer/patient safety and
quality of care regarding drug therapy of any kind begins with
education. Thus, the best way for patients to help themselves
is for them to learn how to assess each situation, weigh all the
factors, and find out all they can about any OTC drugs they
wish to take before taking them.
Natural Health Products
Many NHPs, including herbs, probiotics, and dietary supplements, are readily available in pharmacies, health food
stores, and grocery stores, as well as in gardens, kitchens, and
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BOX 8.3
PART 1 Pharmacology Basics
Cannabis
Cannabis sativa, or cannabis from the hemp plant, is widely used for
recreational purposes. After tobacco, it is the most frequently smoked
substance worldwide. Cannabinoids are the psychoactive ingredients of
marihuana, of which 1-∆9-trans-tetrahydrocannabinol (THC), concentrated
in the bud of the female plant, is the main psychoactive substance. When
marihuana is smoked, the effect is almost immediate and lasts for one
to three hours. THC is absorbed by most tissues and organs in the body;
however, it is primarily found in fat tissues. The body attempts to eliminate the foreign chemical by chemically transforming THC into metabolites. The half-life of THC for an infrequent user is approximately 1.3
days and for frequent users 5 to 13 days (Sharma, Murthy, & Bharath,
2012). THC metabolites can be found in the urine, the preferred sample,
for up to one week after smoking marihuana. Metabolites can also be
detected retrospectively, in hair. Once incorporated into the growing hair,
the drug can be detected for 90 days after it has been eliminated from
more conventional samples, such as blood and urine (Khajuria & Nayak,
2014). THC acts on cannabinoid receptors on brain cells and triggers a
series of chemical reactions that ultimately lead to the “high” that users
experience. Cannabinoid receptors are found in areas of the brain that
influence pleasure, memory, thought, concentration, sensory and time perception, and coordinated movement. There is evidence that THC acts on
neurotransmitters and exerts either excitatory or inhibitory effects.
Cannabidiol (CBD) is the major nonpsychotropic cannabinoid found in
marihuana. It has shown antiepileptic, anti-inflammatory, antiemetic, muscle relaxing, anxiolytic, neuroprotective, and antipsychotic activity; inhibits
colon cancer cell proliferation; and reduces the psychoactive effects of THC
(Romano, Borrelli, Pagano, et al., 2014). The mode of action of cannabidiol is
not fully understood.
While there is sociopolitical concern around the medical use of marihuana,
and the clinical therapeutic potential for marihuana has not yet been proven
in controlled clinical trials beyond 6 weeks, there is anecdotal evidence that
it may be beneficial in a variety of disorders. In Canada, marihuana is legal
and is authorized based on promising clinical evidence for use as an adjunctive treatment for neuropathic pain in adults with multiple sclerosis and as
adjunctive analgesic treatment in adult patients with advanced cancer, for
acquired immunodeficiency syndrome (AIDS)–related anorexia associated
with weight loss, as well as for severe nausea and vomiting associated with
cancer chemotherapy.
medicine cabinets. As noted earlier in the chapter, among the
more commonly used herbals are aloe, echinacea, feverfew,
garlic, ginger, Ginkgo biloba, ginseng, goldenseal, hawthorn,
St. John’s wort, saw palmetto, and valerian. Although patients
generally self-administer these products and do not perform an
assessment, in various settings, the health care provider may be
able to assess the patient through a head-to-toe physical examination, medical and nursing history, and medication history.
Share with the patient assessment data, factors, and variables
to consider, for the patient’s safety. This sharing of assessment
information allows the health care provider to be sure that the
patient is taking the NHP in as safe a manner as possible.
Many NHPs may lead to a variety of adverse effects. For
example, some may cause dermatitis when used topically,
whereas some taken systemically may be associated with kidney disorders such as nephritis. Therefore, for example, patients
with existing skin problems or kidney dysfunction must seek
medical advice before using certain herbal products. It is also
crucial to patient safety to consider any other contraindications,
cautions, and potential drug–drug and drug–food interactions.
See Natural Health Products on page 104 for more information
on drug interactions.
NURSING DIAGNOSES
Nursing diagnoses appropriate for the patient who is taking
OTC drugs or NHPs include the following (without related
causes because these are too numerous to include):
1. Inadequate physical mobility
2. Reduced memory
3. Inadequate urinary elimination
4. Acute pain or persistent pain
5. Fatigue
6. Activity intolerance
7. Insomnia
8. Inadequate health maintenance
9. Potential for injury
10. Readiness for enhanced self-care
11. Readiness for enhanced knowledge
PLANNING
Goals
1. Patient will be able to increase mobility as tolerated and
without distress.
2. Patient will experience increased alertness and improved
short-term and long-term memory with continued use of the
NHP.
3. Patient will maintain normal elimination patterns during
NHP use.
4. Patient will experience pain relief or relief of the symptoms
of the disease process or injury.
5. Patient will experience an increase in energy and function
(or both).
6. Patient’s tolerance for activity will remain within normal
limits or improve during OTC drug or therapy.
7. Patient will experience limited sleep pattern disturbance
while on OTC drug or NHP therapy.
8. Patient will seek healthy maintenance behaviours, with questions about the OTC drug or NHP (or both), as well as its
action, therapeutic effects versus adverse effects, toxicity,
cautions, contraindications, drug–drug or drug–food interactions, and appropriate dosage formulation administration.
9. Patient will remain free from injury while taking the OTC
drug or NHP (or both).
Expected Patient Outcomes
• Patient states that the actions of the TC drug or
P have
been beneficial, with relief of symptoms and increased physical mobility.
• Patient experiences improving overall well being and health
status, with minimal adverse effects or complications.
• Patient reports any change in orientation to person place or
time or in short-term or long-term memory immediately and
seeks appropriate directions regarding discontinuing therapy.
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
• Patient describes nonpharmacological approaches to the
treatment of acute and persistent pain, such as the use of hot
or cold packs, physiotherapy, massage, relaxation therapy,
biofeedback, imagery, and hypnosis.
• Patient identi es measures to increase urinary elimination
and enhance urinary elimination patterns, such as increasing
fluid intake to six to eight glasses of water per day, unless
contraindicated, and taking time to void at regular intervals.
• Patient takes measures to minimi e fatigue through the use
of NHPs, sleeping 6 to 8 hours per night; increasing fluid
intake; and maintaining an intake of recommended daily
amounts of food, calories, and protein.
• Patient states that the actions of the TC drug or
P or both
have been beneficial, with relief of symptoms and subsequent
increased ability to participate in activities of daily living (ADLs)
as well as increased participation in other physical activities.
• Patient states increased hours of sleep i.e. to hours of
sleep) and less difficulty with onset of sleep while using OTC
drugs, herbal products, or dietary supplements.
• Patient experiences healthier behaviours as a result of health
maintenance, by being more knowledgeable about self-medication administration with OTC drugs or NHPs.
• Patient inquires of pharmacist or health care provider about
the safe, daily, healthy maintenance behaviour of taking
NHPs and deciphers information appropriately.
• Patient states the importance of taking drugs as directed and
of immediately reporting any severe adverse effects or complications associated with the use of an OTC drug or NHP to
the health care provider and pharmacist and contacting the
poison control centre, if needed.
• Patient is able to self administer TC drugs or
Ps as
directed and with proper administration technique (e.g.,
transdermal patch, suppository, liquid, quick-dissolve tablet), with minimal adverse effects and a decrease in potential
for self-injury.
IMPLEMENTATION
With OTC drugs and NHPs, patient education is an important
strategy to enhance patient safety. Patients need to receive as
107
much information as possible about the safe use of these products and to be informed that, even though these are not prescription drugs, they are not completely safe and are not without
toxicity. Include in the patient instructions information about
safe use, frequency of dosing and dose specifics about how to
take the medication (e.g., with food or at bedtime), as well as
strategies to prevent adverse effects, drug interactions, and toxicity. Another consideration is the dosage form, because a variety
of dosage forms are available, such as liquids, tablets, enteric-coated tablets, transdermal patches, gum, and quick-dissolve
tablets or strips. Instructions must be provided and the need to
recheck dosage emphasized. For transdermal patches (e.g., for
smoking cessation), it is important to emphasize proper use and
application. As previously mentioned, many consumers believe
that there are no risks if a medication is available OTC or is a
“natural” substance. See Box 8.1 for more information about the
criteria for moving a drug from prescription to OTC status. The
fact that a drug is an NHP does not mean that it can be safely
administered to children, infants, pregnant or lactating women,
or patients with certain health conditions that put them at risk.
EVALUATION
Patients taking OTC drugs or NHPs need to carefully monitor
themselves for unusual or adverse reactions and therapeutic
responses to the medication to prevent overuse and overdosing.
The range of therapeutic responses will vary, depending on the
specific drug and the indication for which it is used. Therapeutic
responses also vary depending on the drug’s action—a few
examples include decreased pain; decreased stiffness and
swelling in joints; decreased fever; increased ease of carrying
out ADLs; increased hair growth; increased ease in breathing;
decreased constipation, diarrhea, bowel irritability, or gastrointestinal reflux or hyperacidity; resolution of allergic symptoms;
decreased vaginal itching and discharge; increased healing;
increased sleep; and decreased fatigue or improved energy.
For more specific nursing diagnoses, planning with goals and
outcome criteria, implementation, and evaluation regarding various OTC drugs and NHPs, see the appropriate chapters later in
the textbook; Table 8.1 provides cross-references to these chapters.
CASE STUDY
Over-the-Counter Drugs and Natural Health Products
Jag, a 28-year-old graduate student, is at the student health
clinic for a physical examination that is required before he
goes on a research trip out of the country. As he completes
the paperwork, he says to the nurse, “The form is asking about
my medications. I don’t have any prescribed medicines, but I
take several herbal products and OTC medicines. Do you need
to know about these?”
1. How should the nurse answer Jag?
On the form, Jag lists the following items:
1 low-dose (81 mg) aspirin daily to prevent blood clots
Sleepwell® herbal product with valerian at night, if needed
Benadryl®, as needed for allergies, especially at night
Stress Away® herbal product with ginseng, as needed
Generic ibuprofen, 3 or 4 tablets three times a day for muscle aches from
working out
Memory Boost® herbal product with Ginkgo biloba every morning
2. Examine the products on Jag’s list, and state whether there are any concerns with interactions or adverse effects. It may be necessary to refer to
descriptions of the individual herbal products (see the inside back cover of
this textbook for a complete listing of Natural Health Products boxes located
throughout the textbook) or to the appropriate drug chapters for more information.
3. Upon further questioning, Jag remembers that he has had problems with
“acid stomach” for about a year and takes Maximum Strength Pepcid®
AC-OTC, as needed, to manage this problem. What concerns, if any, are there
about this?
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
108
PART 1 Pharmacology Basics
PAT I E N T T E A C H I N G T I P S
• Provide verbal and written information about how to choose
an appropriate OTC drug or NHP, as well as information
about correct dosing, common adverse effects, and possible
interactions with other medications.
• Many patients believe that there are no risks if a medication
is herbal and “natural” or if it is sold OTC, so provide adequate education about the drug or product as well as all of
the advantages and disadvantages of its use because this is
crucial to patient safety.
• Provide instructions on how to read TC and
P labels.
Encourage patients to read the ingredients if using more
than one product, as an ingredient or chemical may occur in
both products. For example, a multivitamin supplement may
contain ginseng, and taking additional ginseng supplements
may lead to toxicity. Another example is with products containing acetaminophen (Tylenol). If patients take acetaminophen and then also take a cold/flu product, there may also
be acetaminophen in that product, and consequently the risk
of adverse effects and toxicity increases.
• Emphasi e the importance of taking all TC drugs herbals, and dietary supplements with extreme caution and being
aware of all the possible interactions and concerns associated
with the use of these products.
• Instruct patients that all health care providers e.g. nurses
dentists, osteopathic and chiropractic physicians) need to be
aware of the use of any OTC drugs and NHPs (and, of course,
any prescription drug use).
• Encourage ournalling of any improvement of symptoms
noted with the use of a specific OTC drug or NHP.
• Encourage the use of appropriate and authoritative resources
for patient information, such as a registered pharmacist, literature provided from the drug company or pharmacist, and
web-based information from reliable sites, at an appropriate
reading level for patients (e.g., www.Webmd.com).
• Instruct patients that all medications including TC drugs
and NHPs, should be kept out of the reach of children and
pets.
• Provide thorough instructions regarding the various dosage
forms of OTC drugs and NHPs.
• Provide speci c instructions such as how to mix powders
and how to properly use transdermal patches, inhalers, ointments, lotions, nose drops, ophthalmic drops, elixirs, suppositories, vaginal suppositories or creams, and all other
dosage forms (see Chapter 10); also provide information
about proper storage and cleansing of any equipment.
KEY POINTS
• Consumers use
Ps therapeutically for the treatment of
diseases and pathological conditions, prophylactically for
long-term prevention of disease, and proactively as agents
for the maintenance of health and wellness.
•
ealth Canada has established the MedE ect program to
track adverse events or problems as a result of drug therapy.
The toll-free number is 1-866-678-6789 for marketed health
products, including prescription and nonprescription medications and NHPs. Consumers and health care providers
may report adverse events anonymously and without consequence.
•
Ps are approved by ealth Canada with speci c labelling
requirements to provide adequate instructions for use and
warnings.
• The fact that a drug is an
P or an TC medication is
no guarantee that it can be safely administered to children,
infants, pregnant or lactating women, or patients with certain health conditions that may put them at risk.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. Which statement is true about current Canadian legislation
regarding NHPs?
a. Herbals were regulated in the early 1900s in reference to
their efficacy and toxicity.
b. The Natural and Non-prescription Health Products
Directorate (NNHPD) regulates the safety, efficacy, and
quality of NHPs.
c. The Marihuana for Medical Purposes Regulations allow
access to and possession of marihuana for individuals.
d. The NNHPD was specifically designed to encourage the
freedom of choice and philosophical and ethnocultural
diversity of NHPs.
2. What information about NHPs is important for the nurse to
communicate to patients?
a. Natural health and OTC products are not approved by
Health Canada and are under strict regulation.
b. These products are scrutinized for safety and tested
repeatedly by Health Canada.
c. No adverse effects are associated with these agents
because they are “natural” and may be purchased without
a prescription.
d. Labelling is not 100% reliable for the provision of proper
instructions or warnings, and the products should be
taken with caution.
3. A nurse is taking a patient’s drug history and questions
the patient about the use of OTC medications. The patient
responds by saying, “Oh, I frequently take something for my
headaches, but I didn’t mention it because aspirin is nonprescription.” Which of the following would be the best response
from the nurse to the patient?
a. “That’s true; OTC drugs are generally not harmful.”
b. “Aspirin is one of the safest drugs out there.”
CHAPTER 8 Over-the-Counter Drugs and Natural Health Products
c. “Although aspirin is over the counter, it is still important
to know why you take it, how much you take, and how
often.”
d. “We need you to be honest about the drugs you are taking.
Are there any others that you haven’t told us about?”
4. When making a home visit to a patient who was recently discharged from the hospital, the nurse notes that the patient
has a small pack over her chest and that the pack has a strong
odour. She also is drinking herbal tea. When asked about the
pack and the tea, the patient indicates that “My grandmother
never used medicines from the doctor. She told me this plaster and tea were all I would need to fix things.” Which of the
following responses by the nurse would be most appropriate?
a. “You really should listen to what the doctor told you if you
want to get better.”
b. “What’s in the plaster and the tea? When do you usually
use them?”
c. “These herbal remedies rarely work, but if you want to use
them, then it is your choice.”
d. “It’s fine if you want to use this home remedy, as long as
you use it with your prescription medicines.”
5. The nurse is taking a health history from a patient. The patient
reports taking an herbal supplement that contains kava, to
help with relaxation. The nurse notes that the patient’s skin
and sclera have a yellow tinge. Which of the following nursing actions would be most appropriate?
a. Report this incident to MedEffect.
b. Notify the provincial or territorial pharmaceutical association.
109
c. Contact the supplement manufacturer.
d. No other action is needed.
6. The nurse is reviewing a patient’s drug history, and during
the interview, the patient asks, “Why are some drugs over the
counter and others are not?” Which of the following criteria
for OTC status would be most appropriate for the nurse to
consider when planning her response to the patient? (Select
all that apply.)
a. The condition must be diagnosed by a health care provider.
b. The benefits of correct usage of the drug outweigh the
risks.
c. The drug has limited interaction with other drugs.
d. The drug is easy to use.
e. The drug company sells OTC drugs at lower prices.
7. A patient comes to the clinic reporting elbow pain after an
injury. He states that he has been taking two pain pills, eight
times a day, for the past few days. The medication bottle contains acetaminophen, 325-mg tablets. Calculate how much
medication he has been taking per day. Is this a safe dose of
this medication?
8. The nurse is reviewing definitions for a pharmacology review
class. Which of these products would be categorized as “prescription drugs”? (Select all that apply.)
a. Acetaminophen (Tylenol®)
b. Warfarin (Coumadin)
c. Ginkgo biloba
d. Morphine sulphate
e. Diphenhydramine (Benadryl®)
CRITICAL THINKING ACTIVITIES
1. The nurse is discussing OTC drugs and NHPs with neighbours. One neighbour comments, “Oh, OTC drugs and NHPs
are safe. As long as you use the recommended amounts, there
won’t be any bad side effects.” What is the best response from
the nurse?
2. The nurse is teaching a patient about pain control at home
with OTC products. What teaching points are priorities
during the discussion with the patient?
3. A patient tells the clinic nurse that he has been taking a
“blood thinner” for several months and wants to ask about
taking Ginkgo biloba to prevent memory loss. He says his
sister uses it and it “works wonders.” He also says, “I think
it would be safe because I can buy it at the grocery store.
They wouldn’t sell harmful drugs.” What is the nurse’s best
response to this patient? (You may need to look up the drug
warfarin and the herbal product elsewhere in the textbook.)
For answers see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
e-LEARNING ACTIVITIES
REFERENCES
Website
•
•
•
•
•
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
Barry, A. R. (2018). Patients’ perceptions of use of natural health
products. Canadian Pharmacists Journal, 151(4), 254–262. https://
doi.org/10.1177/1715163518779409.
Benzie, I. F. F., & Wachtel-Galor, S. (Eds.). (2011). Herbal medicine:
Biomolecular and clinical aspects (2nd ed.). Boca Raton, FL: CRC
Press.
Do, T. T. (2015). Medical marijuana legal in all forms, Supreme Court
rules. Retrieved from http://www.cbc.ca/news/politics/medicalmarijuana-legal-in-all-forms-supreme-court-rules-1.3109148.
110
PART 1 Pharmacology Basics
Fraser Institute. (2017). Complementary and alternative medicine: Use
and public attitudes 1997, 2006, and 2016. Retrieved from https://
www.fraserinstitute.org/studies/complementary-and-alternative-medicine-use-and-public-attitudes-1997-2006-and-2016.
Goldman, R. (2011). Treating cough and cold: Guidance for caregivers of children and youth. Paediatrics and Child Health, 16(9),
564–566.
Government of Canada. (2018). Cannabis for medical purposes under
the Cannabis Act: Information and improvements. Retrieved from
https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/medical-use-cannabis.html.
Hampton, L. M., Nguyen, D. B., Edwards, J. R., et al. (2013). Cough
and cold medication adverse events after market withdrawal
and labeling revision. Pediatrics, 132(6), 1047–1054. https://doi.
org/10.1542/peds.2013-2236.
Health Canada. (2012). About natural health products. Retrieved from
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/conseng.php.
Health Canada. (2015). Natural and non-prescription health products.
Retrieved from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php.
Health Canada. (2018a). Non-prescription drug labels. Retrieved
from https://www.canada.ca/en/health-canada/topics/buyingusing-drug-health-products-safely/non-prescription-drug-labels.
html.
Health Canada. (2018b). Natural and non-prescription health products
directorate. Retrieved from https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/healthproducts-food-branch/natural-non-prescription-health-products-directorate.html.
Khajuria, H., & Nayak, B. P. (2014). Detection of ∆9-tetrahydrocannabinol (THC) in hair using GC–MS. Egyptian Journal of Forensic
Sciences, 4(1), 17–20. https://doi.org/10.1016/j.ejfs.2013.10.001.
Liperoti, R., Betrano, D. L., Bernabei, R., et al. (2017). Herbal medications in cardiovascular medicine. Journal of the American College
of Cardiology, 69, 1188–1199.
Necyk, C., Barnes, J., Tsuyuki, R. T., et al. (2013). How well do pharmacists know their patients? A case report highlighting natural
health product disclosure. Canadian Pharmacists Journal, 146(4),
202–209. https://doi.org/10.1177/1715163513493387.
Ramsay, C. (2009). Unnatural regulation: Complementary and
alternative medicine policy in Canada. Studies in health care policy.
Retrieved from https://www.fraserinstitute.org/sites/default/files/
UnnaturalRegulation.pdf.
Romano, B., Borrelli, F., Pagano, E., et al. (2014). Inhibition of colon
carcinogenesis by a standardized Cannabis sativa extract with high
content of cannabidiol. Phytomedicine: International Journal of
Phytotherapy and Phytopharmacology, 21(5), 631–639. https://doi.
org/10.1016/j.phymed.2013.11.006.
Sharma, P., Murthy, P., & Bharath, M. M. S. (2012). Chemistry, metabolism, and toxicology of cannabis: Clinical implications. Iran
Journal of Psychiatry, 7(4), 149–156.
Shehab, N., Schaefer, M. K., Kegler, S. R., et al. (2010). Adverse events
from cough and cold medications after a market withdrawal of
products labeled for infants. Pediatrics, 126(6), 1100–1107. https://
doi.org/10.1542/peds.2010-1839.
Sullivan, J. E., & Farrar, H. C. (2011). Fever and antipyretic use in
children. Pediatrics, 127(3), 580–587. https://doi.org/10.1542/
peds.2010-3852.
Tachjian, A., Vigar, M., & Jahangir, A. (2010). Use of herbal products
and potential interactions in patients with cardiovascular disease.
Journal of the American Association of Cardiology, 55(6), 515–525.
https://doi.org/10.1016/j.jacc.2009.07.074.
Walji, R., Boon, H., Barnes, J., et al. (2010). Consumers of natural health products: Natural-born pharmacovigilantes? BMC
Complementary and Alternative Medicine, 10(8). https://doi.
org/10.1186/1472-6882-10-8.
World Health Organization. (2015). Essential medicines and health
products. Traditional medicine: Definitions. Retrieved from http://
www.who.int/medicines/areas/traditional/definitions/en/.
9
Vitamins and Minerals
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Discuss the importance of the various vitamins and
minerals to the normal functioning of the human body.
2. Briefly describe the various acute and chronic disease states
and conditions that may lead to various imbalances in
vitamin and mineral imbalances.
3. Discuss the pathologies that result from vitamin and
mineral imbalances.
4. Describe the treatment of these vitamin and mineral
imbalances.
5. Identify mechanisms of action, indications, cautions,
contraindications, drug interactions, dosages,
recommended daily allowances, and routes of
administration of each of the vitamins and minerals.
6. Develop a collaborative plan of care regarding the use
of vitamins and minerals that includes all phases of the
nursing process.
KEY TERMS
Beriberi A disease of the peripheral nerves caused by a
dietary deficiency of thiamine (vitamin B1). Symptoms
include fatigue, diarrhea, weight loss, edema, heart failure,
and disturbed nerve function. (p. 119)
Coenzyme A nonprotein substance that combines with a
protein molecule to form an active enzyme. (p. 112)
Enzymes Specialized proteins that catalyze chemical
reactions. (p. 112)
Fat-soluble vitamins Vitamins that can be dissolved (i.e., are
soluble) in fat. (p. 112)
Minerals Inorganic substances that are ingested and attach to
enzymes or other organic molecules. (p. 112)
Pellagra A disease resulting from a deficiency of niacin or
a metabolic defect that interferes with the conversion of
tryptophan to niacin (vitamin B3). (p. 119)
DRUG PROFILES
Rhodopsin The purple pigment in the rods of the retina,
formed by the protein opsin and a derivative of retinol
(vitamin A). (p. 114)
Rickets A condition caused by a deficiency of vitamin D.
(p. 116)
Scurvy A condition caused by a deficiency of ascorbic acid
(vitamin C). (p. 123)
Tocopherols Biologically active chemicals that make up
vitamin E compounds. (p. 117)
Vitamins Organic compounds essential in small quantities
for normal physiological and metabolic functioning of the
body. (p. 111)
Water-soluble vitamins Vitamins that can be dissolved (i.e.,
are soluble) in water. (p. 112)
riboflavin (vitamin B2), p. 120
ascorbic acid (vitamin C), p. 124
thiamine (vitamin B1), p. 120
calcifediol (vitamin D), p. 117
vitamin A, p. 114
calcitriol (vitamin D), p. 117
vitamin E, p. 118
calcium, p. 125
vitamin K1, p. 119
cyanocobalamin (vitamin B12), p. 123
zinc, 127
dihydrotachysterol (vitamin D), p. 117
Key drug
ergocalciferol (vitamin D), p. 117
magnesium, p. 126
niacin (vitamin B3), p. 121
HIGH-ALERT DRUGS
magnesium, p. 126
phosphorus, p. 127
pyridoxine (vitamin B6), p. 122
111
112
PART 1 Pharmacology Basics
OVERVIEW
For the body to grow and maintain itself, it needs the essential
building blocks provided by carbohydrates, fats, and proteins.
Vitamins and minerals are needed to efficiently utilize these nutrients. Vitamins are organic molecules needed in small quantities
for normal metabolism and other biochemical functions, such as
growth and repair of tissue. Equally important are minerals, inorganic elements found naturally in the earth. Enzymes are proteins
secreted by cells; they act as catalysts to induce chemical changes
in other substances. A coenzyme is a substance that enhances or
is necessary for the action of enzymes. Many enzymes are useless
without the appropriate vitamins and minerals that cause them
to function properly. Both vitamins and minerals act primarily
as coenzymes, binding to enzymes (or other organic molecules)
to activate anabolic (tissue-building) processes in the body. For
example, coenzyme A is an important carrier molecule associated
with the citric acid cycle, one of the body’s major energy-producing
metabolic reactions. However, it requires pantothenic acid (vitamin B5) to complete its function in the citric acid cycle.
Vitamins and minerals are essential in our lives, whether or
not we make conscious food choices. The 2019 Health Canada
food guide (Health Canada, 2019a) recommends a variety of vegetables, fruits, proteins, and whole grain foods to help ensure that
daily requirements of vitamins and minerals are met by ingestion
of fluids and balanced meals. Ingesting food maintains adequate
stores of essential vitamins and minerals, serves to preserve intestinal structure, provides chemicals for hormones and enzymes,
and prevents harmful overgrowth of bacteria.
Various illnesses can cause acute or chronic deficiencies of vitamins, minerals, electrolytes, and fluids. These conditions require
replacement or supplementation of these nutrients. Common
examples include extensive burn injuries and acquired immune
deficiency syndrome (AIDS). Excessive loss of vitamins and minerals may also be the result of poor dietary intake, an inability to
swallow after cancer chemotherapy or radiation, or mental health
disorders such as anorexia nervosa. Poor dietary absorption can
also be caused by various gastrointestinal (GI) malabsorption syndromes such as celiac disease, Crohn’s disease, or cystic fibrosis. In
addition, drug and alcohol misuse are frequently associated with
inadequate nutritional intake and absorption that warrants vitamin and mineral supplementation. Deficiencies in dietary protein, fat, and carbohydrates are also common. These nutrients are
discussed in Chapter 42. Because of some of their distinct properties and functions in the body regarding blood formation, iron
and folic acid (vitamin B9) are discussed separately, in Chapter 55.
Vitamins
The human body requires vitamins in specific minimum amounts
on a daily basis, and these can be obtained from both plant and animal food sources. In some cases, the body synthesizes some of its
own vitamin supply. Supplemental amounts of vitamin B complex
and vitamin K are synthesized by normal bacterial flora in the GI
tract. Vitamin D can be synthesized by the skin when exposed to
sunlight.
In Canada, vitamins and minerals are considered natural health
products (NHPs) and are governed under the Natural Health
TABLE 9.1
Fat- and Water-Soluble Vitamins
FAT-SOLUBLE
WATER-SOLUBLE
Designation Alternate Name
Designation
Vitamin B
Alternate
Complex
Name
vitamin A
retinol
vitamin B1
thiamine
vitamin D
D3,
cholecalciferol
D2,
ergocalciferol;
dihydrotachysterol
vitamin B2
riboflavin
vitamin B3
niacin
vitamin E
tocopherols
vitamin B5
pantothenic acid
vitamin K
K1, phytonadione
K2, menaquinone
vitamin B6
vitamin B9
vitamin B12
vitamin B7
vitamin C
pyridoxine
folic acid
cyanocobalamin
biotin
ascorbic acid
Products Regulations. Health Canada requires mandatory detailed
nutritional information to be listed on any packaged food product (Health Canada, 2019b). The values that appear on the labels
are the percent daily values and indicate what percentage of the
dietary reference intakes (DRIs) for a specific nutrient is met by
a single serving of the food product. Information regarding DRIs
and nutrition labelling is available from the following websites:
1. Health Canada Food and Nutrition: Dietary Reference
Intakes (Health Canada, 2013)
2. Health Canada: Dietary References Intakes Tables: recommended intakes for individuals (Health Canada, 2019c),
available at http://www.hc-sc.gc.ca/fn-an/nutrition/reference/
table/index-eng.php
Vitamins are classified as either fat-soluble or water-soluble.
Water-soluble vitamins can be dissolved in water and are easily excreted in the urine. Fat-soluble vitamins are dissolvable in
fat. Because water-soluble vitamins (the B-complex group and
vitamin C) cannot be stored in the body over long periods, daily
intake is required to prevent the development of deficiencies.
Conversely, fat-soluble vitamins (vitamins A, D, E, and K) do not
need to be taken daily unless one is inadequate, because substantial amounts are stored in the liver and fatty tissues. Deficiencies
of these vitamins occur only after prolonged deprivation from an
adequate supply or from disorders that prevent their absorption.
Table 9.1 lists the fat-soluble and water-soluble vitamins.
One controversial topic regarding vitamins is that of nutrient
“megadosing,” as a strategy both for health promotion and maintenance and for treatment of various illnesses. Some patients with
cancer elect to use supplemental megadosing of specific nutrients
in hopes of strengthening their body’s response to more conventional cancer treatments. Megadosing refers to taking doses of a
nutrient that are 10 or more times the recommended amount.
A related term was coined in 1968 by the Nobel prize–winning
chemist, Linus Pauling. He defined orthomolecular medicine to be
“the preventive or therapeutic use of high-dose vitamins to treat
disease.” The best-known claim of Dr. Pauling was that megadoses
of vitamin C (at more than 100 times the Canadian recommended
CHAPTER 9 Vitamins and Minerals
dietary allowance [RDA]) could prevent or cure the common cold
and cancer. Many studies since have not substantiated this claim.
However, there are some situations in which nutrient megadosing
is known to be helpful, including the following:
•
hen concurrent long term drug therapy depletes vitamin
stores or otherwise interferes with the function of a vitamin.
A common clinical example is the use of vitamin B6 (pyridoxine) supplementation in patients receiving the drug isoniazid for the treatment of tuberculosis (see Chapter 46).
• In I malabsorption syndromes such as those seen in patients
with severe colitis and cystic fibrosis (all major nutrient classes,
including protein, fat, carbohydrates, vitamins, and minerals).
• or the treatment of pernicious anemia which results from
vitamin B12 (cyanocobalamin) deficiency. The GI tract uses
a complex mechanism to drive cyanocobalamin absorption.
Specifically, a glycoprotein known as intrinsic factor is secreted
by the parietal cells of the gastric glands (see Chapter 55).
Intrinsic factor facilitates absorption of cyanocobalamin in the
intestine. hen this process is compromised e.g. by disease
administration of megadoses of cyanocobalamin can bypass
this absorption mechanism by allowing a small amount of the
vitamin to diffuse on its own through the intestinal mucosa.
•
hen the vitamin acts as a drug when megadosed. The most
common example is niacin (vitamin B3, also called nicotinic
acid). At doses of up to 20 mg daily, it functions as a vitamin, but
at dosages 50 to 100 times higher, it reduces blood levels of both
triglycerides and low-density lipoprotein (LDL) cholesterol (see
Chapter 28).
In contrast with the aforementioned examples, there are some
situations in which nutrient megadosing is known to be harmful.
For example, any excess of one or more nutrients can result in deficiencies of other nutrients because of their chemical “competition”
for sites of absorption in the intestinal mucosa. This is likely to be
the case with megadosing of minerals, such as with calcium, copper, iron, and zinc, and is less likely to result from vitamin megadosing. Vitamin megadosing can lead to toxic accumulation known as
hypervitaminosis, especially with the fat-soluble vitamins, A, D, and
K. Vitamin E appears safer, however, even at doses 10 to 20 times
the recommended DRI. Hypervitaminosis is much less likely to
occur with the water-soluble vitamins (B complex and C) because
they are readily excreted through the urinary system. Nevertheless,
it is known that megadosing with vitamin B6 (pyridoxine) at 50 to
100 times the DRI can nonetheless cause nerve damage.
A person with an illness may be less tolerant of nutrient megadosing, although megadosing regimens are often prescribed to them.
For example, megadosing may be more of a strain for a patient
whose GI tract is already weakened by illness. Megadosing can
interfere with chemotherapy drugs as well as with radiation treatments, because these therapies work to destroy cancer cells through
oxidation processes. Nutritional supplementation with antioxidants
may impede such treatment mechanisms. Patients need to tell their
health care providers about any unusual nutritional regimens that
they plan to try, especially if they have a serious illness.
Fat-Soluble Vitamins
Fat-soluble vitamins are not readily excreted in the urine and
are stored in the body. Thus, daily ingestion of these vitamins
TABLE 9.2
Nutrients
113
Food Sources of Selected
Vitamins/Minerals Food Sources
vitamin A
Liver; fish; dairy products; egg yolks; dark green,
leafy, yellow–orange vegetables and fruits
vitamin D
Dairy products, fortified cereals and fortified
orange juice, liver, fish liver oils, saltwater fish,
butter, eggs
vitamin E
Fish, egg yolks, meats, vegetable oils, nuts, fruits,
wheat germ, grains, fortified cereals
vitamin K
Cheese, spinach, broccoli, Brussels sprouts, kale,
cabbage, turnip greens, soybean oils
vitamin B1 (thiamine)
Yeast, liver, enriched whole-grain products, beans
vitamin B2 (riboflavin)
Meats, liver, dairy products, eggs, legumes, nuts,
enriched whole-grain products, green leafy
vegetables, yeast
vitamin B3 (niacin)
Liver, turkey, tuna, peanuts, beans, yeast, enriched
whole-grain breads and cereals, wheat germ
vitamin B6 (pyridoxine)
Organ meats, meats, poultry, fish, eggs, peanuts,
whole-grain products, vegetables, nuts, wheat
germ, bananas, fortified cereals
vitamin B12
(cyanocobalamin)
Liver, kidney, shellfish, poultry, fish, eggs, milk,
blue cheese, fortified cereals
vitamin C (ascorbic
acid)
Broccoli, green peppers, spinach, Brussels sprouts,
citrus fruits, tomatoes, potatoes, strawberries,
cabbage, liver
calcium
Dairy products, fortified cereals and
calcium-fortified orange juice, sardines, salmon
magnesium
Meats, seafood, milk, cheese, yogurt, green leafy
vegetables, bran cereal, nuts
phosphorus
Milk, yogurt, cheese, peas, meats, fish, eggs
zinc
Red meats, liver, oysters, certain seafood, milk
products, eggs, beans, nuts, whole grains,
fortified cereals
Source: © All rights reserved. Canadian Nutrient File, Health Canada.
(2015). Adapted and reproduced with permission from the Minister of
Health, 2015.
is not necessary to maintain good health and, in fact, is more
likely to result in hypervitaminosis.
The fat-soluble vitamins are A, D, E, and K. As a group, they
share the following characteristics:
• They are present in both plant and animal foods.
• They are stored primarily in the liver.
• They exhibit slow metabolism or breakdown.
• They are excreted via the feces.
• They can reach toxic levels hypervitaminosis) if excessive
amounts are consumed. Owing to their ability to accumulate in the body, fat-soluble vitamins have a higher potential
for toxicity than water-soluble vitamins do. Iron-containing
vitamins are the most toxic.
Table 9.2 lists the food sources for several nutrients.
Vitamin A
Vitamin A (retinol) is derived from animal fats such as those
found in dairy products, eggs, meat, liver, and fish liver oils. It is
also derived from carotenes, which are found in plants (green and
114
PART 1 Pharmacology Basics
yellow vegetables, yellow fruits). Therefore, vitamin A is an exogenous substance for humans because it must be obtained from
either plant or animal foods. There are more than 600 naturally
occurring carotenoid compounds in plant-based foods. Of these,
40 to 50 occur commonly in the human diet. Beta carotene is the
most prevalent of these, followed by alpha carotene and cryptoxanthin. These are known as provitamin A carotenoids because they
are all metabolized to various forms of vitamin A in the body.
Mechanism of Action and Drug Effects
Vitamin A is essential for night vision and for normal vision
because it is part of one of the major retinal pigments called rhodopsin. Beta carotene is metabolized in the body to retinal (retinaldehyde), and some of this retinal is reduced to the alcohol
compound known as retinol. Retinol is involved in the maintenance of the integrity of mucosal and epithelial surfaces as well
as cholesterol and steroid synthesis. The remainder of the retinal may be oxidized to the carboxylic acid compound, retinoic
acid. Unlike retinal, retinoic acid has no direct role in vision,
but it is essential for normal cell growth and differentiation and
for the development of the physical shapes of the body’s many
parts—a process known as morphogenesis. It is also involved in
the growth and development of bones and teeth and in other
body processes, including reproduction, integrity of mucosal
and epithelial surfaces, and cholesterol and steroid synthesis.
Indications
Supplements of vitamin A may be used to satisfy normal body
requirements or an increased demand such as in infants and in
pregnant and nursing women. A normal diet usually provides
adequate amounts of vitamin A, but in cases of excessive need
or inadequate dietary intake, vitamin A supplementation is indicated. Symptoms of vitamin A deficiency include night blindness,
xerophthalmia, keratomalacia (softening of the cornea), hyperkeratosis of both the stratum corneum (outermost layer of the
skin) and the sclera (outermost layer of the eyeball), reduced
infant growth, generalized weakness, and increased susceptibility of mucous membranes to infection. Vitamin A–related compounds, such as isotretinoin, are also used to treat various skin
conditions, including acne, psoriasis, and keratosis follicularis.
Contraindications
Contraindications to vitamin A supplementation include
known allergy to the individual vitamin product; known
current state of hypervitaminosis; and excessive supplementation beyond recommended guidelines, especially in oral
malabsorption syndromes. Vitamin A is considered highly
teratogenic in pregnancy, particularly in the first 8 weeks,
with daily intake more than 10 000 units (Rosenbloom, 2014).
Adverse Effects
There are minimal acute adverse effects associated with normal
vitamin A ingestion. Only after long-term excessive ingestion
of vitamin A do symptoms appear. Adverse effects are usually
noticed in bones, mucous membranes, the liver, and the skin.
Table 9.3 lists some of the symptoms of long-term excessive
ingestion of vitamin A.
TABLE 9.3
Vitamin A: Adverse Effects
Body System Adverse Effects
Central nervous
Headache, increased intracranial pressure, lethargy,
malaise
Gastrointestinal
Nausea, vomiting, anorexia, abdominal pain, jaundice
Integumentary
Dry skin, pruritus, increased pigmentation, night sweats
Metabolic
Hypomenorrhea, hypercalcemia
Musculoskeletal
Arthralgia, reduced growth
Toxicity and Management of Overdose. The major toxic
effects of vitamin A result from ingestion of excessive amounts,
which occurs most commonly in children. A few hours after
administration of an excess dose of vitamin A, irritability,
drowsiness, vertigo, delirium, coma, vomiting, or diarrhea may
occur. In infants, excessive amounts of vitamin A can cause an
increase in intracranial pressure, resulting in symptoms such
as bulging fontanelles, headache, papilledema, exophthalmos
(bulging eyeballs), and visual disturbances. Papilledema is
the presence of edematous fluid, often including blood, in the
optic disc. This is the portion of the eye in the back of the
retina, where nerve fibres converge to form the optic nerve.
Over several weeks, a generalized peeling of the skin and
erythema (skin reddening) may occur. These symptoms seem
to disappear a few days after discontinuation of the drug, which
is the only treatment necessary in situations of overdose.
Interactions
Vitamin A is absorbed less when used together with lubricant
laxatives and cholestyramine. In addition, the concurrent use of
isotretinoin and vitamin A supplementation can result in additive effects and possible toxicity.
Dosages
For dosage information on vitamin A, refer to the table on p.
115.
DRUG PROFILE
There are three forms of vitamin A: retinol, retinyl palmitate,
and retinyl acetate. Medications containing vitamin A may
require a prescription, but many over-the-counter products,
such as vitamin A–containing multivitamins, are also available.
All vitamin A products are safe to use during pregnancy.
vitamin A
Vitamin A, also known as retinol, retinyl palmitate, and retinyl
acetate, is available in a variety of oral forms. Doses for vitamin
A are expressed as retinol activity equivalents (RAEs). One RAE
is approximately equal to the following:
PHARMACOKINETICS
Onset of Peak Plasma Elimination
Route Action
Concentration Half-Life
PO
N/A
4 hr
50–100 days
Duration
of Action
Unknown
Dosages
Selected Vitamins*
Drug
Pharmacological
Class
Usual Dosage Range
Vitamin D–Active Compounds
calcifediol
Fat-soluble
calcitriol
Fat-soluble
cholecalciferol (vitamin
D3)
Fat-soluble
Vitamin B–Active Compounds
vitamin B1
Water-soluble,
(thiamine)
B complex group
vitamin B2
(riboflavin)
Water-soluble,
B complex group
vitamin B3 (niacin,
niacinamide)
Water-soluble,
B complex group
vitamin B6
Water-soluble,
B complex group
vitamin B12
(cyanocobalamin)
Water-soluble,
B complex group
Vitamins A, C, E, and K
vitamin A
Fat-soluble
Indications/Uses
Adults and children
PO: 50 mcg once daily
Hypocalcemia in patients receiving
hemodialysis
Adults and children 6 yr and older
PO/IV: 0.25–1 mcg/day
Adults and children older than 9 yr
600–800 units/day (max 4 000 units/day)
Children 4–8 yr
600 units/day (max 3 000 units/day)
Children aged 0–4 yrs
400–600 units/day (max 1 000–3 000/day)
Hypoparathyroidism; hypocalcemia
in patients receiving hemodialysis
Vitamin D deficiency
Adults
100 mg/day until normal dietary intake is established
Children
5–30 mg/day × 30 days
Adults
PO: 5–30 mg/day
Children
3–10 mg/day
Adults
PO: 1.5–6 g/day
300–500 mg/day
Children
IV: Up to 300 mg/day
Adults
PO/IV: 2.5–10 mg/day
Children
PO/IV: 5–25 mg/day × 3 wk, then give multivitamin product
Adults
PO/IV: 100–200 mg/day
Children
PO: 100–200 mg/kg/day
Adults and children
IM/Subcut: 100 mcg/mo
PO: 50–100 mcg/day
Alcohol-induced deficiency
Beriberi
Adults
100,000 units/day IM × 3 days then 50,000 units/day IM for 2 weeks
(deficiency)
Children 1–18 yr
PO: 30–3 000 mcg RAE/day
Deficiency
Deficiency
Dyslipidemia
Pellagra (deficiency)
Deficiency
Deficiency
Drug-induced neuritis (e.g.,
isoniazid for tuberculosis)
Anemia
Deficiency; anemia
vitamin C
(ascorbic acid)
Water-soluble
Adults
PO/IV/IM/SC: 100–250 mg daily, bid × 3 wk
Children
PO/IV: 100–300 mg/day
Deficiency (scurvy)
vitamin E
Fat-soluble
Adults
PO: 60–75 units/day
Deficiency
vitamin K
(phytonadione)
Fat-soluble
Adults
IM/Subcut: 2.5–10 mg single dose
For reversal of warfarin, the ORAL route is preferred in non-bleeding
patients depending on their INR (usual dose is 1-5mg PO)
Infants and children
IM/Subcut: 2.5–10 mg single dose; may repeat in 4–6 hr
Infants
IM/Subcut: 1 mg single dose
Deficiency; warfarin-induced
hypoprothrombinemia
*Adequate dietary intake is always preferred over supplementation to prevent vitamin deficiencies.
Hemorrhagic disease of newborn
116
•
•
•
•
PART 1 Pharmacology Basics
mcg of retinol either dietary or supplemental
mcg of supplemental β-carotene
mcg of dietary β-carotene
mcg of dietary carotenoids
Vitamin D
Vitamin D, also called the sunshine vitamin, is responsible for
the proper utilization of calcium and phosphorus in the body.
The two most important members of the vitamin D family are
vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol).
They have different sites of origin but similar functions in the
body. Ergocalciferol is plant derived and is therefore obtained
through dietary sources. The natural form of vitamin D produced in the skin by ultraviolet irradiation from the sun is
chemically known as 7-dehydrocholesterol. It is more commonly
referred to as cholecalciferol. This endogenous synthesis of
vitamin D3 usually produces sufficient amounts to meet daily
requirements. Vitamin D is obtained through both endogenous
synthesis and consumption of vitamin D2–containing foods
such as fish oils, salmon, sardines, and herring; fortified milk,
bread, and cereals; and animal livers, tuna fish, eggs, and butter.
Normal serum levels are 50 nmol/L.
Mechanism of Action and Drug Effects
The basic function of vitamin D is to regulate the absorption and
subsequent utilization of calcium and phosphorus. It is also necessary for the normal calcification of bone. Vitamin D, in coordination with parathyroid hormone and calcitonin, regulates serum
calcium levels by increasing calcium absorption from the small
intestine and extracting calcium from the bone. Ergocalciferol
and cholecalciferol are inactive and require transformation into
active metabolites for biological activity. Both vitamin D2 and
vitamin D3 are biotransformed in the liver by the actions of the
parathyroid hormone. The resulting compound, calcifediol, is
then transported to the kidney, where it is converted to calcitriol,
which is believed to be the most physiologically active form of
vitamin D. Calcitriol promotes the intestinal absorption of calcium and phosphorus and the deposition of calcium and phosphorus into the structure of teeth and bones.
The drug effects of vitamin D are similar to those of vitamin A
and essentially all vitamin and mineral compounds. It is used as a
supplement to satisfy normal daily requirements or an increased
demand, as in infants and in pregnant and nursing women.
Indications
Vitamin D can be used either to supplement dietary intake of
vitamin or to treat a de ciency of vitamin . hen used to
supplement dietary intake, it is given prophylactically to prevent
deficiency-related problems, and it is recommended for breastfed
infants. Vitamin D may also be used to treat and correct the results
of a long-term deficiency that leads to such conditions as infantile
rickets, tetany (involuntary sustained muscular contractions), and
osteomalacia (softening of bones). Rickets is specifically a vitamin D
deficiency state. Symptoms include soft, pliable bones, which causes
deformities such as bowlegs and knock-knees; nodular enlargement
on the ends and sides of the bones; muscle pain; enlarged skull;
chest deformities; spinal curvature; enlargement of the liver and
TABLE 9.4
Vitamin D: Adverse Effects
Body System
Adverse Effects
Cardiovascular
Hypertension, dysrhythmias
Central nervous
Fatigue, weakness, drowsiness, headache
Gastrointestinal
Nausea, vomiting, anorexia, cramps, metallic taste, dry
mouth, constipation
Genitourinary
Polyuria, albuminuria, increased blood urea nitrogen level
Musculoskeletal
Decreased bone growth, bone pain, muscle pain
spleen; profuse sweating; and general tenderness of the body when
touched. Vitamin D can also help promote the absorption of phosphorus and calcium. For this reason, its use is important in preventing osteoporosis. Because of the role of vitamin D in the regulation
of calcium and phosphorus, it may be used to correct deficiencies
of these two elements. Other uses include dietary supplementation
and treatment of osteodystrophy, hypocalcemia, hypoparathyroidism, pseudohypoparathyroidism, and hypophosphatemia. Many
patients have vitamin D deficiency, and it is common to see doses of
1 000 to 2 000 or more units daily prescribed.
There were some early indications that maintaining adequate
levels of vitamin D may have a protective effect and lower the
risk of developing multiple sclerosis. However, there have been
no current, evidence-informed studies to support this theory.
Contraindications
Contraindications to vitamin D products include known allergy
to the product, hypercalcemia, kidney dysfunction, kidney
stones, and hyperphosphatemia.
Adverse Effects
Few acute adverse effects are associated with normal vitamin D
ingestion. Only after long-term excessive ingestion of vitamin D do
symptoms appear. Such effects are usually noticed in the GI tract or
the central nervous system (CNS) and are listed in Table 9.4.
Toxicity and Management of Overdose. The major toxic
effects from ingesting excessive amounts of vitamin D occur
most commonly in children. Discontinuation of vitamin D and
reduced calcium intake reverse the toxic state. Toxicity occurs
because vitamin D is fat-soluble and is stored in the body’s fat
supply. The amount of vitamin D considered to be toxic varies
considerably among individuals. In adults, a dose of 50 000 IU
per day of vitamin D can eventually increase blood levels to more
than 374 nmol/L; at these concentrations, abnormal levels of
calcium and phosphorus can also build up in the blood. However,
10 000 to 14 000 units daily have not produced toxic effects.
The toxic effects of vitamin D are those associated
with hypertension, such as weakness, fatigue, headache,
anorexia, dry mouth, metallic taste, nausea, vomiting,
ataxia, and bone pain. If not recognized and treated, these
symptoms can progress to impairment of kidney function
and osteoporosis.
Interactions
Reduced absorption of vitamin D occurs with the concurrent
use of lubricant laxatives and cholestyramine.
CHAPTER 9 Vitamins and Minerals
Dosages
For dosage information on vitamin D, refer to the table on p. 115.
DRUG PROFILES
vitamin D
There are four forms of vitamin D: calcifediol, calcitriol, dihydrotachysterol, and ergocalciferol. Vitamin D is available in overthe-counter preparations—such as multivitamin products—or by
prescription. Vitamin D is considered safe to use during pregnancy
as long as the patient is not dosed at higher levels than recommended.
calcitriol
Calcitriol (Rocaltrol®), a steroid hormone, is the 1,25-dihydroxylated form of cholecalciferol (vitamin D3). It is a vitamin-D analogue used for the management of hypocalcemia in patients with
chronic kidney failure, on dialysis, and for the management of
secondary hyperparathyroidism in patients not yet on dialysis.
Calcitriol is also used in the treatment of hypoparathyroidism and
pseudohypoparathyroidism, vitamin D–dependent rickets, hypophosphatemia, and hypocalcemia in premature infants. Calcitriol
is available for oral use.
PHARMACOKINETICS
Onset of
Route Action
PO
Less than 3 hr
Peak Plasma
Concentration
3–6 hr
Elimination Duration
Half-Life
of Action
3–6 hr
3–5 days
dihydrotachysterol
Dihydrotachysterol is a vitamin-D analogue that is administered orally, once daily, for the treatment of any of the previously
mentioned conditions. It is available orally in combination with
calcium carbonate.
ergocalciferol
Ergocalciferol (Osto-D2®) is vitamin D2. It is indicated for use in
patients with GI, liver, or biliary disease associated with malabsorption of vitamin-D analogues. It is available orally.
PHARMACOKINETICS (ERGOCALCIFEROL, VITAMIN D2)
Onset of Peak Plasma
Route Action
Concentration
PO
30 days
Unknown
Elimination Duration
Half-Life
of Action
19 days
Months to
years
Vitamin E
TABLE 9.5
117
Vitamin E: Adverse Effects
Body System
Adverse Effects
Central nervous
Gastrointestinal
Fatigue, headache, blurred vision
Nausea, diarrhea, flatulence
Genitourinary
Increased blood urea nitrogen level
Musculoskeletal
Weakness
deficiency syndrome for vitamin E occurs in premature infants.
In this situation, vitamin E deficiency may result in irritability,
edema, thrombosis, and hemolytic anemia.
The drug effects of vitamin E are not as well defined as those
of the other fat-soluble vitamins. It is believed to protect polyunsaturated fatty acids, a component of cellular membranes. It
has also been shown to hinder the deterioration of substances
such as vitamin A and ascorbic acid (vitamin C), two substances
that are highly oxygen sensitive and readily oxidized; thus, it
acts as an antioxidant.
Indications
Vitamin E is most commonly used as a dietary supplement to
augment current daily intake or to treat a deficiency. Premature
infants are at greatest risk of complications from vitamin E deficiency. Vitamin E has received much attention for its function
as an antioxidant. Free radical damage contributes to the early
stages of atherosclerosis and may also contribute to cancer, heart
disease, and numerous other chronic diseases. Early studies such
as the Nurses’ Health Study showed promise for vitamin E’s role
as a scavenger for the damaging free radicals, with beneficial
effects for patients with cancer, heart disease, Alzheimer’s disease, premenstrual syndrome, and sexual dysfunction. Results
from the Heart Outcomes Prevention Evaluation (HOPE) trial
also showed no benefit of 4 years of vitamin E supplementation among the 9 500 men and women already diagnosed with
heart disease or at high potential for it. In fact, when the HOPE
trial was extended for an additional 4 years, researchers found
a higher risk of heart failure in those subjects. The Heart and
Stroke Foundation (2019) recommends a healthy diet that
includes vitamin E (e.g., pecans, walnuts, almonds) (https://
www.heartandstroke.ca/get-healthy/healthy-eating/fats-andoils). As well, vitamin E supplement use has no immediate or
long-term effects on cancer risk (Chan, 2015).
Free radicals can also damage collagen and cause skin dryness, fine lines, and wrinkles. Vitamin E is available in many
skin creams and ointments; it is thought to provide protection
against ultraviolent radiation.
Four biologically active chemicals, called tocopherols (alpha [α],
beta [β], gamma [γ], and delta [δ]), make up the vitamin E compounds. Alpha-tocopherol is the most biologically active, natural
form of vitamin E and can come from plant and animal sources.
Contraindications
Contraindications for vitamin E include known allergy to a specific vitamin E product. There are currently no approved injectable forms of this vitamin.
Mechanism of Action and Drug Effects
Vitamin E is a powerful biological antioxidant and an essential component of the diet. Its exact nutritional function has
not been fully demonstrated. The only recognized significant
Adverse Effects
Few acute adverse effects are associated with normal vitamin E
ingestion, because it is relatively nontoxic. Adverse effects are
usually noticed in the GI tract or CNS and are listed in Table 9.5.
118
PART 1 Pharmacology Basics
Dosages
For dosage information on vitamin E, refer to the table on p.
115.
DRUG PROFILE
vitamin E
Vitamin E is available as an over-the-counter medication. It has
four forms: alpha (α), beta (β), gamma (γ), and delta (δ) tocopherol. It is available in many multivitamin preparations and is
also available by prescription. Vitamin E products are usually
contraindicated only in cases of known drug allergy. Vitamin E
(Aquasol E®) activity is generally expressed in US Pharmacopeia
(USP) or international units. It is available for oral and injection
use.
Vitamin K
Vitamin K is the last of the four fat-soluble vitamins (A, D,
E, and K). There are three types of vitamin K: phytonadione
(vitamin K1), menaquinone (vitamin K2), and menadione
(vitamin K3). The body does not store large amounts of vitamin K; however, vitamin K2 is synthesized by the intestinal
flora, which provides an endogenous supply. Vitamin K is
essential for the synthesis of blood coagulation factors, which
takes place in the liver. Vitamin K–dependent blood coagulation factors are factors II, VII, IX, and X. Other names for
these clotting factors are as follows: factor II (prothrombin),
factor VII (proconvertin), factor IX (Christmas factor), and
factor X (Stuart-Prower factor). Minimum daily requirements
have been estimated at 1 to 5 mcg/kg for infants and 0.03 mcg/
kg for adults. There is no commercially available oral formulation of vitamin K1; however, the injectable formulation has
been used orally. It is usually administered by intramuscular
or subcutaneous route, but the intravenous route can be used
cautiously.
Vitamin K also plays a role in converting osteocalcin, a
non-collagen protein found in the bone, into its active form.
Osteocalcin, once activated, serves to anchor calcium into place
within the bone.
Mechanism of Action and Drug Effects
Vitamin K activity is essential for effective blood clotting
because, as noted earlier, it facilitates the liver biosynthesis of
factors II, VII, IX, and X. Vitamin K deficiency results in coagulation disorders caused by hypoprothrombinemia. Coagulation
defects affecting these clotting factors can be corrected with
administration of vitamin K. Vitamin K deficiency is rare
because intestinal flora is normally able to synthesize sufficient
amounts. If a deficiency develops, it can be corrected with vitamin K supplementation.
Indications
Vitamin K is indicated for dietary supplementation and for
treatment of deficiency states. Although rare, deficiency states
can develop with inadequate dietary intake or inhibition
TABLE 9.6
Vitamin K: Adverse Effects
Body System
Adverse Effects
Central nervous
Gastrointestinal
Headache, brain damage (large doses)
Nausea, decreased liver enzyme levels
Hematological
Hemolytic anemia, hemoglobinuria, hyperbilirubinemia
Integumentary
Rash, urticaria
of the intestinal flora resulting from the administration of
broad-spectrum antibiotics. Deficiency states can also be seen
in newborns because of malabsorption attributable to inadequate amounts of bile. For this reason, infants born in hospitals are often given a prophylactic intramuscular dose of
vitamin K on arrival to the nursery. Vitamin K may also be
used to reverse excessive anti-coagulation if the patient has
evidence of bleeding (as measured by the international normalized ratio [INR]).
Vitamin K deficiency can also result from the administration and pharmacological action of the oral anticoagulant
warfarin sodium (see Chapter 27 . arfarin sodium’s anticoagulant effects occur by inhibiting vitamin K–dependent
clotting factors II, VII, IX, and X in the liver. Administration
of vitamin K overrides the mechanism by which the anticoagulant inhibits production of vitamin K–dependent clotting
factors. Thus, vitamin K can be used to reverse the effects of
warfarin sodium. It is important to note that when vitamin
K is used in this manner, the patient becomes unresponsive
to warfarin sodium for approximately 1 week after vitamin
K administration. hen vitamin K1 is reduced, it can lead
to inadequate mineralization of the bone due to diminished
functioning of osteocalcin. Osteoporosis increases one’s risk
of fracture. It has been shown that the greater the deficiency
in vitamin K, the greater the severity of the fracture.
Contraindications
The only usual contraindication to treatment with vitamin K is
known drug allergy.
Adverse Effects
Vitamin K is relatively nontoxic and thus causes minimal
adverse effects. Severe reactions limited to hypersensitivity or
anaphylaxis have occurred rarely, during or immediately after
intravenous administration. Adverse effects usually result from
injection-site reactions and hypersensitivity. See Table 9.6 for a
list of such major effects by body system.
Toxicity and Management of Overdose. Toxicity is limited
primarily to use in the newborn. Hemolysis of red blood
cells (RBCs) can occur, especially in infants with low levels
of glucose-6-phosphate dehydrogenase (G6PD). In severe
cases, replacement with blood products may be indicated.
Dosages
For dosage information on vitamin K, refer to the table on p.
115.
CHAPTER 9 Vitamins and Minerals
Vitamin B1
DRUG PROFILE
The most commonly used form of vitamin K is phytonadione
(vitamin K1), which is available by prescription, only in parenteral form. Menadione (vitamin K3) is not available in Canada
and is contraindicated in patients with a known hypersensitivity, in patients who are in the last few weeks of pregnancy, and in
patients with severe liver disease. Vitamin K must be used with
caution in patients taking warfarin sodium.
vitamin K1
Vitamin K1 (phytonadione) is available in injectable form and
is usually administered by the intramuscular or subcutaneous
route. Because of its potential to cause anaphylaxis (due to the
formulation), for intravenous use it is usually diluted and given
over to minutes. hen used to reverse the e ects of warfarin sodium, Vitamin K is given IV and not intramuscularly.
PHARMACOKINETICS
Onset of
Route Action
IV
1–2 hr
Peak Plasma Elimination
Concentration Half-Life
12–14 hr
1.2 hr
Duration
of Action
24 hr
PO
24–48 hours
12–24hrs
6–10 hours
Water-Soluble Vitamins
119
10 hrs (+/– 6hrs)
The water-soluble vitamins include the vitamin B complex and vitamin C (ascorbic acid). They are present in a variety of plant and animal food sources. The vitamin B complex is a group of 10 vitamins
that are often found together in food, although they are chemically
dissimilar and have different metabolic functions. Because the B
vitamins were originally isolated from the same sources, they were
grouped together as B-complex vitamins. Vitamin C (ascorbic acid),
the other principal water-soluble vitamin, is concentrated in citrus
fruits and is not classified as part of the B complex. The numeric
subscripts associated with the various B vitamins reflect the order
in which they were discovered. In clinical practice, some B vitamins
are more often referred to by their common name, whereas others
are more often referred to by their numeric designation.
For example, vitamin B12 is used more often in clinical practice than the corresponding common name, cyanocobalamin.
However, folic acid is rarely referred to as vitamin B9, although
this would also be correct. The most commonly used B-complex
vitamins, as well as vitamin C, are listed in Table 9.1. Folic acid
(vitamin B9) has a special role in hematopoiesis and therefore is
described further in Chapter 55.
ater soluble vitamins are a chemically diverse group sharing only the characteristic of being dissolvable in water. Like
fat-soluble vitamins, they act primarily as coenzymes or oxidation-reduction agents in important metabolic pathways. Unlike
fat-soluble vitamins, water-soluble vitamins are not stored in
the body in appreciable amounts. Their water-soluble properties promote urinary excretion and reduce their half-life in the
body. Therefore, dietary intake must be adequate and regular or
deficiency states will develop. The body excretes what it does not
need, which makes toxic reactions to water-soluble vitamins rare.
A deficiency of vitamin B1 (thiamine) results in the classic disease beriberi or ernicke’s encephalopathy cerebral beriberi .
Common findings in beriberi include brain lesions, polyneuropathy of peripheral nerves, serous effusions (abnormal collections of
fluids in body tissues), and cardiac anatomical changes. Vitamin
deficiency can result from poor diet, extended fever, hyperthyroidism, liver disease, alcoholism, malabsorption, and pregnancy
and breastfeeding. Normal serum levels are 0.75–222 nmol/L.
Mechanism of Action and Drug Effects
Vitamin B1 (thiamine) is an essential precursor for the formation
of thiamine pyrophosphate. hen thiamine combines with adeno
sine triphosphate (ATP), the result is thiamine pyrophosphate coenzyme. This is required for the citric acid cycle (Krebs cycle), a major
part of carbohydrate metabolism, as well as several other metabolic
pathways. In addition, thiamine plays a key role in the integrity of
the peripheral nervous system, cardiovascular system, and GI tract.
Indications
The essential role of thiamine in many metabolic pathways
makes it useful in treating a variety of metabolic disorders.
These include subacute necrotizing encephalomyelopathy,
maple syrup urine disease, and lactic acidosis associated with
pyruvate carboxylase enzyme deficiency and hyper-β-alaninemia. Some of the deficiency states treated by thiamine are beriberi ernicke’s encephalopathy syndrome peripheral neuritis
associated with pellagra (niacin deficiency), and neuritis of
pregnancy. Thiamine is used as a dietary supplement to prevent or treat deficiency in cases of malabsorption, such as that
induced by alcoholism, cirrhosis, or GI disease. Other situations
in which thiamine may have therapeutic value are poor appetite,
ulcerative colitis, chronic diarrhea, and cerebellar syndrome or
ataxia (inadequate muscular coordination). Although it has
been suggested, studies do not support the use of oral vitamin B
as an insect repellent.
Contraindications
The only usual contraindication to any of the B-complex vitamins is known allergy to a specific vitamin product.
Adverse Effects
Adverse effects are rare but include hypersensitivity reactions,
nausea, restlessness, pulmonary edema, pruritus, urticaria,
weakness, sweating, angioedema, cyanosis, and cardiovascular
collapse. Administration by intramuscular injection can produce local tenderness, and intravenous injections can produce
anaphylaxis.
Interactions
Thiamine is incompatible with alkaline- and sulfite-containing
solutions.
Dosages
For dosage information on vitamin B1, refer to the table on p.
115.
120
PART 1 Pharmacology Basics
DRUG PROFILE
thiamine
DRUG PROFILE
riboflavin
Thiamine is contraindicated in individuals with a known hypersensitivity to it. It is available for both oral (in combination) and
parenteral use. It is safe to use during pregnancy.
Riboflavin (vitamin B2) is needed for normal respiratory reactions. It is a safe, nontoxic water-soluble vitamin with almost
no adverse effects. It is available for oral and parenteral use. It is
safe to use during pregnancy.
PHARMACOKINETICS
Route
PO
Onset of
Action
Unknown
Peak Plasma
Elimination Duration
Concentration Half-Life
of Action
1–2 hr
1.2 hr
24 hr
Vitamin B2
A deficiency of vitamin B2 (riboflavin) results in cutaneous,
oral, and corneal changes that include cheilosis (chapped or fissured lips), seborrheic dermatitis, and keratitis.
Mechanism of Action and Drug Effects
Riboflavin serves several important functions in the body.
Riboflavin is converted into two coenzymes (flavin mononucleotide and flavin adenine dinucleotide) that are essential
for tissue respiration. Riboflavin also plays an important part
in carbohydrate catabolism. Another B vitamin, vitamin B6
(pyridoxine), requires riboflavin for activation. Riboflavin is
also needed to convert tryptophan into niacin and to maintain
erythrocyte integrity. Deficiency is rare and does not usually
occur in healthy people.
Indications
Riboflavin is used primarily as a dietary supplement and for
treatment of deficiency states. Patients who may experience
riboflavin deficiency include those with long-standing infections, liver disease, alcoholism, or malignancy and those taking
probenecid. Riboflavin supplementation may also be beneficial in the treatment of microcytic anemia; acne; migraine
headache; congenital methemoglobinemia (presence in the
blood of an abnormal, nonfunctional hemoglobin pigment);
muscle cramps; and Gopalan’s syndrome, a symptom of suspected riboflavin (and possibly pantothenic acid [vitamin B5])
deficiency that involves a sensation of tingling in the extremities (for this reason, it is also called burning feet syndrome).
Contraindications
The only usual contraindication to riboflavin is known allergy
to a given vitamin product.
Adverse Effects
Riboflavin is a safe and effective vitamin; to date, no adverse
effects or toxic effects have been reported. In large doses, riboflavin will discolour urine to yellow–orange.
Dosages
For dosage information on riboflavin, refer to the table on p.
115.
PHARMACOKINETICS
Route
PO
Onset of
Action
Unknown
Peak Plasma
Concentration
Unknown
Elimination Duration
Half-Life
of Action
66–84 min
24 hr
Vitamin B3
The body is able to produce a small amount of vitamin B3 (niacin) from dietary tryptophan, an essential amino acid occurring
in dietary proteins and some commercially available nutritional
supplements. A dietary deficiency of niacin will produce the classic symptoms known as pellagra. Symptoms of pellagra include
various psychotic disorders; neurasthenic syndrome; crusting, erythema, and desquamation of the skin; scaly dermatitis;
inflammation of the oral, vaginal, and urethral mucosa, including glossitis (inflamed tongue); and diarrhea or bloody diarrhea.
Mechanism of Action and Drug Effects
The metabolic actions of niacin (vitamin B3) are not because of
niacin in the ingested form but rather its metabolic product, nicotinamide. Nicotinamide is required for numerous metabolic reactions, including those involved in carbohydrate, protein, purine,
and lipid metabolism, as well as tissue respiration (Fig. 9.1). A key
example involves two compounds, nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate
(NADP), both of which are necessary for the carbohydrate pathway known as glycogenolysis (the breakdown of stored glycogen to
usable glucose). The parent compound, niacin, also has a pharmacological role as an antilipemic drug (see Chapter 28). The doses
of niacin required for its antilipemic effect are substantially higher
than those required for the nutritional and metabolic effects.
Indications
Niacin is indicated for the prevention and treatment of pellagra, a condition caused by a deficiency of vitamin B3 that is
most commonly the result of malabsorption. It is also used for
management of certain types of dyslipidemia (see Chapter 28).
Niacin also has a beneficial effect in peripheral vascular disease.
Contraindications
Niacin, unlike certain other B-complex vitamins, has additional contraindications besides drug allergy. These include liver disease, severe
hypotension, arterial hemorrhage, and active peptic ulcer disease.
Adverse Effects
The most frequent adverse effects associated with the use of niacin are flushing, pruritus, and GI distress. These usually subside
with continued use and are most frequently seen when larger
CHAPTER 9 Vitamins and Minerals
Tryptophan
(from dietary m
protein) sou ino
rc r
e
121
(NAD)
Nicotinamide adenine dinucleotide
n
Nicotinamide
m
so aj
ur or
ce
Niacin
m
Nicotinamide adenosine dinucleotide phosphate
Direct dietary
consumption
of niacin
(NADP)
Fig. 9.1 Niacin, once in the body, is converted to nicotinamide adenine dinucleotide (NAD) and nicotinamide
adenine dinucleotide phosphate (NADP), which are coenzymes needed for many metabolic processes.
Pyridoxine (Vitamin B6):
Adverse Effects
TABLE 9.7
Niacin: Adverse Effects
Body System
Adverse Effects
Cardiovascular
Postural hypotension, dysrhythmias
Body System
Adverse Effects
Central nervous
Headache, dizziness, anxiety
Central nervous
Paresthesias, flushing, warmth, headache, lethargy
Gastrointestinal
Nausea, vomiting, diarrhea, peptic ulcer
Genitourinary
Hyperuricemia
Hepatic
Abnormal liver function tests, hepatitis
Integumentary
Flushing, dry skin, rash, pruritus, keratosis
Metabolic
Decreased glucose tolerance
TABLE 9.8
doses of niacin are used in the treatment of dyslipidemia. Table
9.7 lists adverse effects by body system.
Dosages
For dosage information on niacin, refer to the Drug Profile box
below.
DRUG PROFILE
niacin
Niacin is used to treat pellagra, dyslipidemias, and peripheral
vascular disease. Its use must be monitored closely in patients
who have a history of coronary artery disease, gallbladder disease, jaundice, liver disease, or arterial bleeding. Niacin is available for oral use. It is safe to use during pregnancy.
PHARMACOKINETICS (NIACIN, VITAMIN B3)
Route
PO
Onset of Peak Plasma
Elimination
Action
Concentration Half-Life
30–60 min 45 min
45 min
Vitamin B6
Duration
of Action
Variable
Vitamin B6 (pyridoxine) is composed of three compounds: pyridoxine, pyridoxal, and pyridoxamine. Deficiency of vitamin B6
can lead to a type of anemia known as sideroblastic anemia,
neurological disturbances, seborrheic dermatitis, cheilosis, and
xanthurenic aciduria (formation of xanthine crystals or “stones”
in urine). It may also result in convulsions, especially in neonates and infants; hypochromic microcytic anemia; and glossitis (inflamed tongue) and stomatitis (inflamed oral mucosa).
Pyridoxine deficiency also affects the peripheral nerves, skin,
and mucous membranes. Inadequate intake or poor absorption of pyridoxine causes the development of these conditions.
Vitamin B6 deficiency may occur as a result of uremia, alcoholism, cirrhosis, hyperthyroidism, malabsorption syndromes, and
heart failure. It may also be induced by various drugs, such as
isoniazid and hydralazine.
Mechanism of Action and Drug Effects
Pyridoxine, pyridoxal, and pyridoxamine are all converted in
erythrocytes to the active coenzyme forms of vitamin B6, pyridoxal phosphate and pyridoxamine phosphate. These compounds are necessary for many metabolic functions in the body,
such as protein, carbohydrate, and lipid utilization. They also play
an important part in the conversion of amino acid tryptophan to
niacin (vitamin B3) and the neurotransmitter serotonin. They are
essential in the synthesis of gamma-aminobutyric acid (GABA),
an inhibitory neurotransmitter in the CNS. They are important
in the synthesis of heme and the maintenance of the hematopoietic system. In addition, these substances are necessary for the
integrity of the peripheral nerves, skin, and mucous membranes.
Indications
Pyridoxine is used to prevent and treat vitamin B6 deficiency.
This includes deficiency that can result from therapy with
certain medications, including isoniazid (for tuberculosis)
and hydralazine (for hypertension). Although vitamin B6
deficiency is rare, it can occur in conditions of inadequate
intake or poor absorption of pyridoxine. Seizures that are
unresponsive to usual therapy, morning sickness during
pregnancy, and metabolic disorders may respond to pyridoxine therapy.
Contraindications
The only usual contraindication to pyridoxine use is known
drug allergy.
Adverse Effects
Adverse effects with pyridoxine use are rare and usually do
not occur at normal dosages; high dosages and long-term
use may produce the adverse effects listed in Table 9.8. Toxic
122
PART 1 Pharmacology Basics
Adenosylcobalamin
Fat metabolism
Cyanocobalamin
Carbohydrate metabolism
Methylcobalamin
Protein synthesis
• Growth
• Cell replication
• Hematopoiesis
• Nucleoprotein synthesis
• Myelin synthesis
Fig. 9.2 Cyanocobalamin is a Required Coenzyme for Many Body Processes.
effects are a result of large dosages sustained for several months.
Neurotoxicity is the most likely result, but this will subside upon
discontinuation of the pyridoxine.
Interactions
Pyridoxine reduces the activity of levodopa; therefore, vitamin formulations containing B6 must be avoided in patients
taking levodopa alone. However, the overwhelming majority of patients with Parkinson’s disease take a combination of
levodopa and carbidopa, and this interaction does not occur
with combination therapy.
Dosages
For dosage information on vitamin B6, refer to the table on
p. 115.
DRUG PROFILE
pyridoxine
Pyridoxine is a water-soluble B-complex vitamin composed of
three components: pyridoxine, pyridoxal, and pyridoxamine. It
has several vital roles in the body but is primarily responsible
for the integrity of peripheral nerves, skin, mucous membranes,
and the hematopoietic system. It is available only for oral use. It
is safe to use in pregnancy.
PHARMACOKINETICS
Route
PO
Onset of Peak Plasma
Action
Concentration
Unknown
30–60 min
Elimination Duration
Half-Life
of Action
15–20 days
Unknown
Vitamin B12
Vitamin B12 (cyanocobalamin) is a water-soluble B-complex vitamin that contains cobalt (hence, its name; cyano- means “blue”).
It is synthesized by microorganisms and is present in the body as
two different coenzymes: adenosylcobalamin and methylcobalamin. Cyanocobalamin is a required coenzyme for many metabolic pathways, including fat and carbohydrate metabolism and
protein synthesis. It is also required for growth, cell replication,
hematopoiesis, and nucleoprotein and myelin synthesis (Fig. 9.2).
Vitamin B12 deficiency results in GI lesions, neurological
changes that can result in degenerative CNS lesions, and megaloblastic anemia. The major cause of cyanocobalamin deficiency
is malabsorption. Other possible but less likely causes are poor
diet, chronic alcoholism, and chronic hemorrhage. Normal
serum levels are 118–701 pmol/L.
Mechanism of Action and Drug Effects
Humans must have an exogenous source of cyanocobalamin
because it is required for nucleoprotein and myelin synthesis,
Extrinsic Factor
Cyanocobalamin
Intrinsic Factor
Gastric intrinsic factor
(from the diet)
(from parietal cells)
insic-Intrin
Extr r Comp sic
o
lex
Fact
Absorption from
intestines into
body
Fig. 9.3 Oral absorption of cyanocobalamin requires the presence
of intrinsic factor, which is secreted by gastric parietal cells.
cell reproduction, normal growth, and the maintenance of normal erythropoiesis. The cells that have the greatest requirement
for vitamin B12 are those that divide rapidly, such as epithelial
cells, bone marrow, and myeloid cells.
Reduced sulfhydryl (-5H) groups are required to metabolize fats and carbohydrates and synthesize protein.
Cyanocobalamin is involved in maintaining 5H groups in the
reduced form. Cyanocobalamin deficiency can lead to neurological damage that begins with an inability to produce myelin
and is followed by gradual degeneration of the axon and nerve
head.
Cyanocobalamin activity is identical to the activity of the
antipernicious anemia factor present in liver extract, called
extrinsic factor or Castle factor. The oral absorption of cyanocobalamin (extrinsic factor) requires the presence of intrinsic factor, which is a glycoprotein secreted by gastric parietal
cells. A complex is formed between the two factors, which is
then absorbed by the intestines. This mechanism is depicted in
Fig. 9.3.
Indications
Cyanocobalamin is used to treat deficiency states that develop
because of an insufficient intake of the vitamin. It is also
included in multivitamin formulations that are used as dietary
supplements. Deficiency states are most often the result of malabsorption or poor dietary intake, including consumption of
a strict vegetarian diet, because the primary source of cyanocobalamin is foods of animal origin. The most common manifestation of untreated cyanocobalamin deficiency is pernicious
anemia. The use of vitamin B12 to treat pernicious anemia and
other megaloblastic anemias results in the rapid conversion
of megaloblastic bone marrow to normoblastic bone marrow.
The preferred route of administration of vitamin B12 in treating
megaloblastic anemias is deep intramuscular injection. If not
treated, deficiency states can lead to megaloblastic anemia and
CHAPTER 9 Vitamins and Minerals
TABLE 9.9
Effects
Cyanocobalamin: Adverse
Body System
Adverse Effects
Cardiovascular
Central nervous
Heart failure, peripheral vascular thrombosis,
pulmonary edema
Flushing, optic nerve atrophy
Gastrointestinal
Diarrhea
Integumentary
Pruritus, rash, pain at injection site
Metabolic
Hypokalemia
irreversible neurological damage. Cyanocobalamin is also useful in the treatment of pernicious anemia caused by an endogenous lack of intrinsic factor.
Contraindications
The only usual contraindication to cyanocobalamin (vitamin
B12) is known drug product allergies. This may include sensitivity to the chemical element cobalt, which is part of the structure of cyanocobalamin. Another contraindication is hereditary
optic nerve atrophy (Leber’s disease).
Adverse Effects
Vitamin B12 is nontoxic, and large doses must be ingested to
produce adverse effects, which include itching, transitory diarrhea, and fever. Other adverse effects are listed by body system
in Table 9.9.
Interactions
Concurrent use with anticonvulsants, aminoglycoside antibiotics, or long-acting potassium preparations decreases the oral
absorption of vitamin B12.
Dosages
For dosage information on vitamin B12, refer to the table on p.
115.
DRUG PROFILE
cyanocobalamin
Cyanocobalamin is a water-soluble B-complex vitamin required
for maintenance of body fat and carbohydrate metabolism and
protein synthesis. It is also needed for growth, cell replication,
blood cell production, and the integrity of normal nerve function. Cyanocobalamin is available both as an over-the-counter
preparation and by prescription. Most of the over-the-counter,
cyanocobalamin-containing products are multivitamin preparations, whereas many of the prescription cyanocobalamin-containing products contain large doses for parenteral injection and
are available by prescription only. Cyanocobalamin is safe for use
during pregnancy.
PHARMACOKINETICS (CYANOCOBALAMIN, VITAMIN B12)
Onset of Peak Plasma
Elimination
Route Action
Concentration Half-Life
PO
Unknown
8–12 hr
6 days
Duration
of Action
Unknown
123
Vitamin C
Vitamin C (ascorbic acid) can be used in many therapeutic situations. Prolonged ascorbic acid deficiency results in the nutritional disease scurvy, which is characterized by weakness, edema,
gingivitis and bleeding gums, loss of teeth, anemia, subcutaneous hemorrhage, bone lesions, delayed healing of soft tissues and
bones, and hardening of leg muscles. Scurvy has been recognized
for several centuries, especially among sailors. In 1795, the British
navy ordered ingestion of limes to prevent the disease.
Mechanism of Action and Drug Effects
Vitamin C is reversibly oxidized to dehydroascorbic acid and
acts in oxidation-reduction reactions. It is required for several
important metabolic activities, including collagen synthesis and
the maintenance of connective tissue; tissue repair; maintenance of bone, teeth, and capillaries; and folic acid metabolism
(specifically, the conversion of folic acid into its active metabolite). It is also essential for erythropoiesis. Vitamin C enhances
the absorption of iron and is required for the synthesis of lipids,
proteins, and steroids. It has also been shown to aid in cellular
respiration and resistance to infections.
Indications
Vitamin C is used to treat diseases associated with vitamin C
deficiency and as a dietary supplement. It is most beneficial in
patients who have larger daily requirements because of pregnancy,
lactation, hyperthyroidism, fever, stress, infection, trauma, burns,
smoking, exposure to cold temperatures, and the consumption
of certain drugs (e.g., estrogens, oral contraceptives, barbiturates,
tetracyclines, and salicylates). Because vitamin C is an acid, it can
also be used as a urinary acidifier. The benefits of other uses of
vitamin C are undocumented. For example, taking vitamin C to
prevent or treat the common cold is common practice, but most
large, controlled studies have shown that ascorbic acid has little or
no value as a prophylactic for the common cold.
Contraindications
The only usual contraindication for vitamin C use is known
allergy to a specific vitamin product.
Adverse Effects
Vitamin C is usually nontoxic unless excessive dosages are
consumed. Megadoses can produce nausea, vomiting, headache, and abdominal cramps and will acidify the urine, which
can result in the formation of cystine, oxalate, and urate kidney stones. Furthermore, individuals who discontinue taking
excessive daily doses of ascorbic acid can experience scurvylike
symptoms.
Interactions
Ascorbic acid has the potential to interact with many classes of
drugs. However, clinical experience concerning interactions is
inconclusive. Coadministration with acid-labile drugs such as
penicillin G or erythromycin must be avoided. Large doses of
vitamin C can acidify the urine but may enhance the excretion
of basic (opposite of acidic) drugs and delay the excretion of
acidic drugs.
124
PART 1 Pharmacology Basics
Dosages
For dosage information on vitamin C, refer to the table on p.
115.
Positively charged metallic cations
Metallic elements
Electrolytes
DRUG PROFILE
Negatively charged nonmetallic anions
ascorbic acid
Ascorbic acid is a water-soluble vitamin required for the prevention
and treatment of scurvy. It is also required for erythropoiesis and
the synthesis of lipids, protein, and steroids. It is available both in
over-the-counter preparations such as multivitamin products and
by prescription. Ascorbic acid is available in many oral dosage forms
as well as an injectable form. It is safe to use during pregnancy.
Minerals
Minerals are essential nutrients that are classified as inorganic compounds. They act as building blocks for many body
structures and thus are necessary for a variety of physiological
functions. They are also needed for intracellular and extracellular body fluid electrolytes. Iron is essential for the production of hemoglobin, which is required for transport of oxygen
throughout the body (see Chapter 55). Minerals are necessary
for muscle contraction and nerve transmission and are required
components of essential enzymes.
Mineral compounds are composed of metallic and nonmetallic elements that are chemically combined with ionic
bonds. hen these compounds are dissolved in water they
separate (dissociate) into positively charged metallic cations
and electrolytes or negatively charged nonmetallic anions and
electrolytes (Fig. 9.4). Ingestion of minerals provides essential
elements necessary for vital bodily functions. Elements that
are required in larger amounts are called macrominerals; those
required in smaller amounts are called microminerals or trace
elements. Table 9.10 classifies these nutrient elements as either
macrominerals or microminerals and as metal or nonmetal.
Calcium
Calcium is the most abundant mineral element in the human
body, accounting for approximately 2% of the total body weight.
The highest concentration of calcium is in bones and teeth. The
efficient absorption of calcium requires adequate amounts of
vitamin D. According to Health Canada (2019c), calcium intake
of Canadians is inadequate. Approximately one quarter (23%)
of children ranging from 4 to 8 years, 44% of boys (9–18 years),
and up to 70% of girls (9–18 years) had inadequate intake of
calcium. In Canadian adults, depending on the age group,
approximately 27–80% of men and 48–87% of women have a
high prevalence of inadequate intake of calcium.
Calcium deficiency results in hypocalcemia and can affect
many bodily functions. Causes of calcium deficiency include
inadequate calcium intake and insufficient vitamin D to facilitate
absorption; hypoparathyroidism; and malabsorption syndrome,
especially in older individuals. Calcium deficiency–related disorders include infantile rickets, adult osteomalacia, muscle
cramps, osteoporosis (especially in postmenopausal females),
hypoparathyroidism, and kidney dysfunction. Table 9.11 lists
Nonmetallic
elements
Electrolytes
Fig. 9.4 When Mineral Compounds are Dissolved in Water, they
Separate Into Positively Charged Metallic Cations and Electrolytes
or Negatively Charged Nonmetallic Anions and Electrolytes.
TABLE 9.10
Element
Mineral Elements
Symbol
Type
Ionic/Electrolyte Form
Macrominerals
calcium*
Ca
Metal
Ca2+ calcium cation
chlorine
Cl
Nonmetal
Cl− chloride anion
magnesium*
Mg
Metal
Mg2+ magnesium cation
phosphorus*
P
Nonmetal
PO43− phosphate anion
potassium
K
Metal
K+ potassium cation
sodium
Na
Metal
Na+ sodium cation
sulphur
S
Nonmetal
SO42− sulphate anion
Microminerals
chromium
Cr
Metal
Cr3− chromium cation
cobalt
Co
Metal
Co2+ cobalt cation
copper
Cu
Metal
Cu2+ copper cation
fluorine
F
Nonmetal
F+ fluoride anion
iodine*
I
Nonmetal
I+ iodide anion
iron*
Fe
Metal
Fe2+ ferrous cation
manganese
Mn
Metal
Mn2+ manganese cation
molybdenum
Mo
Metal
Mo6+ molybdenum cation
selenium*
Se
Metal
Se2− selenium cation
zinc*
Zn
Metal
Zn2+ zinc cation
*Mineral elements that have a current recommended daily allowance
(RDA).
the possible causes of calcium deficiency and the resulting disorders. Normal serum levels are 2.05 to 2.55 mmol/L.
Mechanism of Action and Drug Effects
Calcium participates in a variety of essential physiological functions and is a building block for body structures. Specifically, it
is involved in the proper development and maintenance of teeth
and skeletal bones. It is an important catalyst in many of the
coagulation pathways in the blood. Calcium acts as a cofactor
in clotting reactions involving the intrinsic and extrinsic pathways of thromboplastin. It is also a cofactor in the conversion of
prothrombin to thrombin by thromboplastin and the conversion of fibrinogen to fibrin. Calcium is essential for the normal
maintenance and function of the nervous, muscular, and skeletal systems and for cell membrane and capillary permeability. It
is an important catalyst in many enzymatic reactions, including
CHAPTER 9 Vitamins and Minerals
TABLE 9.11
and Disorders
Cause
Calcium Deficiency: Causes
Calcium Salts: Elemental
Calcium Content
TABLE 9.12
Disorder
Calcium Salt
Elemental Calcium Content
(Per Gram)
Inadequate intake
Insufficient vitamin D
Infantile rickets
Adult osteomalacia
Hypoparathyroidism
Muscle cramps
carbonate*
chloride
400 mg (9.96 mmol)
273 mg (13.5 mmol)
Malabsorption syndrome
Osteoporosis
acetate
253 mg (6.3 mmol)
citrate*
211 mg (5.26 mmol)
gluconate*
93 mg (2.32 mmol)
gluceptate
82 mg (2.04 mmol)
glubionate
66 mg (1.64 mmol)
transmission of nerve impulses; contraction of cardiac, smooth,
and skeletal muscles; renal function; respiration; and, as noted
earlier, blood coagulation. Calcium also plays a regulatory role
in the release and storage of neurotransmitters and hormones,
in white blood cell
C and hormone activity in the uptake
and binding of amino acids, and in intestinal absorption of cyanocobalamin (vitamin B12) and gastrin secretion.
Indications
Calcium salts are used for the treatment or prevention of calcium depletion in patients for whom dietary measures are
inadequate. Calcium requirements are also high for growing
children and women who are pregnant or breastfeeding. Many
conditions may be associated with calcium deficiency, including
the following:
• Achlorhydria
• Alkalosis
• Chronic diarrhea
•
yperphosphatemia
•
ypoparathyroidism
• Menopause
• Pancreatitis
• Pregnancy and lactation
• Premenstrual syndrome
• Kidney failure
• Sprue
• Steatorrhea
• itamin de ciency
Calcium is also used to treat various manifestations of established deficiency states, including adult osteomalacia, hypoparathyroidism, infantile rickets or tetany, muscle cramps, and
osteoporosis. In addition, it is used as a dietary supplement for
women during pregnancy and lactation.
More than 12 different selected calcium salts are available
for treatment or nutritional supplementation. Each calcium salt
contains a different amount of elemental calcium per gram of
calcium salt. Table 9.12 lists seven available salts and their associated elemental calcium contents.
Contraindications
Contraindications for administration of exogenous calcium
include hypercalcemia, ventricular fibrillation, and known
allergy to a specific calcium drug product.
Adverse Effects
Although adverse effects and toxicity are rare, hypercalcemia
can occur. Symptoms include anorexia, nausea, vomiting, and
125
*Most commonly used forms for the prevention of osteoporosis.
TABLE 9.13
Calcium Salts: Adverse Effects
Body System
Adverse Effects
Cardiovascular
Gastrointestinal
Hemorrhage, rebound hypertension
Constipation, obstruction, nausea, vomiting,
flatulence
Genitourinary
Kidney dysfunction, kidney stones, kidney failure
Metabolic
Hypercalcemia, metabolic alkalosis
constipation. In addition, when calcium salts are administered
by intramuscular or subcutaneous injection, mild to severe local
reactions, including burning, necrosis and sloughing of tissue,
cellulitis, and soft tissue calcification, may occur. Venous irritation may occur with intravenous administration. Other adverse
effects associated with both oral and parenteral use of calcium
salts are listed in Table 9.13.
Toxicity and Management of Overdose. Long-term excessive
calcium intake can result in severe hypercalcemia, which can
cause heart irregularities, delirium, and coma. Management of
acute hypercalcemia may require hemodialysis, whereas milder
cases will respond to discontinuation of calcium intake.
Interactions
Calcium salts will chelate (bind) with tetracyclines and quinolones to produce an insoluble complex. If hypercalcemia is present in patients taking digoxin, serious cardiac dysrhythmias can
occur. Calcium may interfere with the absorption of thyroid
replacement medications; therefore, it is recommended to take
the thyroid medication 2 hours before taking calcium.
Dosages
For dosage information on calcium and other selected minerals,
refer to the table on p. 127.
DRUG PROFILE
calcium
Calcium salts are primarily used in the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Many calcium salts are available, all
with a different content of elemental calcium per gram of salt.
126
PART 1 Pharmacology Basics
Calcium is available in both oral and parenteral (injectable)
forms. Numerous calcium preparations are available that have
different names and provide different dosages. Consult manufacturer instructions for recommended dosages. The pharmacokinetics of calcium is highly variable and depends on
individual patient physiology and the characteristics of the
specific drug product used. Medication errors and confusion
are common with calcium products because the amount of
salt is not the same as the amount of elemental calcium. For
example, calcium carbonate 1 250 mg is equal to 500 mg of
elemental calcium. Depending on the manufacturer, the drug
may be profiled as 1 250 mg when the tablet is labelled as 500
mg. Additional confusion occurs with the injectable forms,
calcium chloride and calcium gluconate. Calcium chloride
provides about three times as much elemental calcium as calcium gluconate, but they are both ordered as 1 g or 1 ampule.
Calcium chloride can cause severe problems if it infiltrates
from the intravenous line. For that reason, it is recommended
that it be diluted or given through a central line if it is given by
intravenous push. Adding to the confusion is calcium acetate
(acetic acid), which is used not for calcium replacement but
to bind phosphate in patients with kidney disease. Calcium
products are considered safe to use during pregnancy.
Magnesium
Magnesium is one of the principal cations present in the intracellular fluid. It is an essential part of many enzyme systems
associated with energy metabolism. Magnesium deficiency
(hypomagnesemia) is usually caused by (1) malabsorption,
especially in the presence of high calcium intake; (2) alcoholism; (3) long-term intravenous feeding; (4) diuretic use;
and (5) metabolic disorders, including hyperthyroidism and
diabetic ketoacidosis. Symptoms associated with hypomagnesemia include cardiovascular disturbances, neuromuscular impairment, and mental health disorders. Dietary intake
from vegetables and other foods will usually prevent magnesium deficiency. However, magnesium is required in greater
amounts in individuals with diets high in protein-rich foods,
calcium, and phosphorus. Normal serum levels are 0.65 to
1.05 mmol/L.
Mechanism of Action and Drug Effects
The precise mechanism for the effects of magnesium has not
been fully determined. Magnesium is a known cofactor for many
enzyme systems. It is required for muscle contraction and nerve
function. Magnesium produces an anticonvulsant effect by inhibiting neuromuscular transmission for selected convulsive states.
Indications
Magnesium is used for treatment of magnesium deficiency and
as a nutritional supplement in total parenteral nutrition and
multivitamin preparations. It is used as an anticonvulsant in
magnesium deficiency–induced seizures; to manage complications of pregnancy, including pre-eclampsia and eclampsia; as
a tocolytic drug for inhibition of uterine contractions in premature labour; for treatment of acute nephropathy in children;
for management of various cardiac dysrhythmias; and for shortterm treatment of constipation.
Contraindications
Contraindications to magnesium administration include known
drug product allergy, heart block, kidney failure, adrenal gland
failure (Addison’s disease), and hepatitis.
Adverse Effects
Adverse effects of magnesium are due to hypermagnesemia,
which results in tendon reflex loss, difficult bowel movements,
CNS depression, respiratory distress and heart block, and
hypothermia.
Toxicity and Management of Overdose. Toxic effects are
extensions of symptoms caused by hypermagnesemia, a major
cause of which is the long-term use of magnesium products
(especially antacids in patients with kidney dysfunction). Severe
hypermagnesemia is treated with intravenous calcium salt,
administered intravenously, and possibly the diuretic furosemide.
Interactions
The use of magnesium with neuromuscular blocking agents and
CNS depressants produces additive effects.
DRUG PROFILE
magnesium
Magnesium is a mineral that has a variety of dosage forms and
uses. It is an essential part of many en yme systems. hen
absent or diminished in the body, cardiovascular, neuromuscular, and mental health disorders can occur. Magnesium sulphate is the most common form of magnesium used as a mineral
replacement. It is available in injectable form. It is safe to use in
pregnancy.
Phosphorus
Phosphorus is widely distributed in foods, and thus a dietary
deficiency is rare. Deficiency states are primarily due to malabsorption, extensive diarrhea or vomiting, hyperthyroidism, liver
disease, and long-term use of aluminum or calcium antacids.
Normal serum levels are 0.74 to 1.52 mmol/L.
Mechanism of Action and Drug Effects
Phosphorus in the form of the phosphate group or anion (PO43−)
is a required precursor for the synthesis of essential body chemicals and an important building block for body structures.
Phosphorus is required as a structural unit for the synthesis of
nucleic acid and the adenosine phosphate compounds (adenosine monophosphate [AMP], adenosine diphosphate [ADP], and
adenosine triphosphate [ATP]) responsible for cellular energy
transfer. It is also necessary for the development and maintenance of the skeletal system and teeth. Bones contain up to 85%
of the phosphorus content of the body. In addition, phosphorus
is required for the proper utilization of many B-complex vitamins, and it is an essential component of physiological buffering
systems.
CHAPTER 9 Vitamins and Minerals
Dosages
Selected Minerals
Drug
Pharmacological Class
calcium
Mineral salt
carbonate
(Rolaids®,
TUMS®)
Usual
Dosage
Range
Indications/
Uses
PO: 500 mg Antacid, nutri2–4
tional-calcium
times
supplementadaily
tion, hyperphosphatemia
associated with
chronic kidney
failure
Indications
Phosphorus is used for treatment of deficiency states and as a
dietary supplement in many multivitamin formulations.
Contraindications
Contraindications to phosphorus or phosphate administration
include hyperphosphatemia and hypocalcemia.
Adverse Effects
Adverse effects are usually associated with the use of phosphorus replacement products. These effects include diarrhea, nausea, vomiting, and other GI disturbances. Other adverse effects
include confusion, weakness, and breathing difficulties.
Toxicity and Management of Overdose. Toxic reactions to
phosphorus are extremely rare and usually occur after ingestion
of the pure element.
Interactions
Antacids can reduce the oral absorption of phosphorus.
DRUG PROFILES
phosphorus
Phosphorus is a mineral that is essential to our well-being. It is
needed to make energy in the form of ADP and ATP for all bodily
processes. Phosphorus is present in a large number of drug formulations and appears as a phosphate salt (PO4). Phosphorus
should be used with caution in patients with kidney impairment.
zinc
The metallic element zinc is often taken orally in the form of
the sulphate salt as a mineral supplement. Normally a dietary
trace element, zinc plays a crucial role in the enzymatic metabolic reactions involving both proteins and carbohydrates. This
makes it especially important for normal tissue growth and
repair. It therefore also has a major role in wound repair.
NURSING PROCESS
ASSESSMENT
Before administering vitamins, assess the patient for nutritional disorders by reviewing the results of various laboratory
127
tests such as hemoglobulin hematocrit
C and R C counts
serum albumin, and total protein levels. Assess the patient’s
dietary intake, dietary patterns, menu planning, grocery shopping/food practices and habits, and ethnocultural influences
prior to giving any supplemental therapy. Assess contraindications, cautions, and drug interactions before giving any supplemental therapy. For vitamin A deficiencies, perform a baseline
vision assessment, including night vision, and conduct a thorough examination of the skin and mucous membranes and
document the findings. Assess for contraindications to vitamin
A such as known allergy as well as a current state of excessive supplementation or hypervitaminosis. Additionally, assess
for drug interactions with laxatives and cholestyramine leading to possible decreased absorption of the vitamin. Baseline
assessment and documentation of level of consciousness, GI
functioning and concerns, vision, condition of the skin, and
musculoskeletal status are also important due to the adverse
effects and signs and symptoms of toxicity associated with
overdosage of vitamin A (see the pharmacology discussion and
Table 9.3).
For patients who have reduced vitamin D serum levels, perform a baseline assessment of skeletal formation with attention
to any deformities. Serum vitamin D (35 to 150 nmol/L) and
calcium levels are usually ordered as baseline and then during
therapy. It is also important to assess for known contraindications
such as kidney dysfunction and hypercalcemia or hyperphosphatemia. Assess for drug interactions with laxatives and cholestyramine leading to possible decreased absorption of the vitamin.
Before vitamin E is administered, assess patients for hypoprothrombinemia because this condition may occur secondary
to vitamin E deficiency. Document any baseline bleeding or
hematological problems and conduct a thorough skin assessment with attention to skin integrity, presence of any edema,
muscle weakness, easy bruising, or bleeding.
The last of the fat-soluble vitamins, vitamin K, is associated with
clotting function; therefore, prior to its use, measure and document
the patient’s prothrombin time, INR, and platelet counts. Assess the
skin for bruises, petechiae, and erythema. Examine the gums for
gingival bleeding. Assess urine and stool for the presence of blood.
Also assess vital signs with attention to blood pressure and pulse
rate. If intravenous dosage forms are prescribed, baseline assessment must include vital signs because of the risk of anaphylactic
reactions. This is particularly important for vitamin K1 injection
because of an associated higher risk of anaphylaxis. Assessment
of liver function is also important. It is critical to patient safety to
remember that fat-soluble vitamins are all stored in the body tissue
when excessive quantities are consumed and may become toxic if
taken in large doses. Assess and document baseline values of vitamin K; normal ranges are 0.29 to 2.64 nmol/L.
Vitamin B1 (thiamine) hypersensitivity may cause skin rash
and wheezing; therefore, document the presence of any allergic reactions to vitamin B compounds. Also document baseline
assessment of vital signs. Because it is rare for a deficiency of
only one B-complex vitamin to occur, rule out deficiencies of all
the B vitamins before treatment begins. The normal vitamin B1
(thiamine) level is 0.75 nmol/L, and vitamin B12 (cyanocobalamin) levels range from 118 to 701 pmol/L. Urinary thiamine
128
PART 1 Pharmacology Basics
levels may also be ordered (in adults, urinary thiamine levels of
less than 27 mcg/dL indicate deficiency). Vitamin B1 deficiency
may result in ernicke’s encephalopathy see the pharmacology
discussion); thus, there is a need for a thorough mental status
assessment. Thoroughly assess the medication order for accuracy and for route of administration. Drug interactions include
alkaline and sulfite-containing solutions, so be sure to assess for
drugs being administered at the same time. Vitamin B2 (riboflavin) has no major toxic effects or drug interactions, but assessing for known allergy to any vitamin product is important.
Vitamin B3 (niacin) has several important indications. Assess
for contraindications such as liver disease, severe hypotension,
and active peptic ulcer disease. ith vitamin 6 (pyridoxine),
perform a thorough neurological assessment due to associated
neurotoxicity with large dosages. Levodopa is a significant drug
interaction to assess for with pyridoxine because the vitamin
reduces the action of levodopa. Vitamin B12 (cyanocobalamin)
requires thorough assessment of the medication order. Note the
route of administration because the preferred route is deep IM
injection. Drug interactions to assess for include anticonvulsants, aminoglycoside antibiotics, and long-acting potassium
supplements because they decrease the oral absorption of vitamin B12.
Vitamin C (ascorbic acid) is usually well tolerated; however,
assess the patient for any history of nutritional deficits or problems with dietary intake as well as any allergies to a specific
product. Assess for drug interactions that include acid-labile
drugs such as penicillin G or erythromycin. Additionally, it is
important to note that large doses of vitamin C may increase the
excretion of many basic (opposite of acidic) drugs and delay the
excretion of acidic drugs.
ith the minerals calcium and magnesium include in
the baseline assessment allergies, nutritional status, use of
medications, medical history, contraindications, cautions,
and drug interactions. Laboratory studies that may be prescribed include serum calcium (2.05 to 2.55 mmol/L), magnesium (0.65 to 1.05 mmol/L), hemoglobin, hematocrit, and
R C and
C counts. Calcium interacts with many medications, as described previously, so a thorough assessment
of the patient’s medication history is important to patient
safety. The specific interaction of calcium is that of chelation or binding with the drug and, in this case, it is with
levothyroxine, tetracycline and quinolone antibiotics. The
chelation then forms an insoluble complex, rendering the
antibiotic inactive. Another significant interaction occurs
when a patient is hypercalcemic and takes digitalis, with the
result of serious cardiac dysrhythmias. If there is a history of
cardiac disease, a baseline electrocardiogram recording may
be ordered prior to calcium therapy. Because of the various
calcium preparations with different names and doses, always
thoroughly assess the medication order and be certain that
the right product is being given. Also note that the injectable forms of calcium (i.e., calcium chloride and calcium
gluconate) may be easily confused, so be cautious. Assess
patency of the intravenous site, if intravenous dosage forms
are ordered, because infiltrates may lead to severe irritation
of the vein and surrounding tissue.
Magnesium is also associated with several drug interactions. Review for potential interactions before drug therapy is
initiated, such as with CNS depressants and neuromuscular
blocking drugs. Assess the patient’s kidney, heart, and liver functioning. It is important to document neurological functioning
and grading of deep tendon reflexes prior to giving magnesium.
Hyporeflexia may indicate toxicity. It is also important to assess
the health care provider’s order for completeness and reason for
use to fully understand why the drug is being given (e.g., for
replacement, antacid, or laxative purposes). In addition, thoroughly assess any order for the use of calcium, magnesium, or
zinc within total parenteral nutrition infusions.
NURSING DIAGNOSES
• Inadequate physical mobility resulting from poorly developed muscles from vitamin D or vitamin E deficiency or
from fatigue resulting from poor nutrition and vitamin B
deficiency
• Inadequate tissue integrity resulting from vitamin C de ciency and subsequent decreased healing
• Potential for in ury as a result of possible night blindness or
altered vision due to vitamin A deficiency
PLANNING
Goals
• Patient will regain or maintain normal or near normal physical mobility and musculoskeletal functioning.
• Patient will maintain intact skin and tissue integrity.
• Patient will remain free from in ury.
Expected Patient Outcomes
• Patient increases mobility daily with performance of activities of daily living and usual exercise regimen or as prescribed.
• Patient states measures to increase energy stamina and
strength, such as increase in dietary consumption of well-balanced diet and fluids with vitamin or mineral supplementation.
• Patient states measures to minimi e in ury and maximi e
intactness of skin and mucous membranes, such as performing frequent mouth care, keeping skin clean and dry and
applying moisturizers as needed, as well as drinking at least
180 to 240 mL of water per day.
• Patient states measures to prevent in ury such as minimi ing
obstacles in the home setting, removing area or throw rugs,
and adding night lights.
• Patient states measures to replace vitamin A de ciencies
through replacement therapy and dietary intake, such as
increased intake of liver, fish, dairy products, egg yolks, and
yellow–orange vegetables and fruits.
IMPLEMENTATION
Before administering vitamin A or any vitamin or supplement,
document the patient’s dietary intake for the preceding 24
hours. Document any signs and symptoms of hypervitaminosis and hypercarotenemia (excess vitamin A). Vitamin D is
available in over-the-counter products (e.g., multivitamins)
CHAPTER 9 Vitamins and Minerals
or by prescription (10 000 units), but attention to the product prescribed is important to patient safety. Combination
intramuscular dosage forms are available for those with GI,
liver, biliary, or malabsorptive syndromes. During therapy,
advise the patient to report any palpitations or unresolved
nausea, vomiting, constipation, or muscle pain. Instruct the
patient to take vitamin B1 (thiamine) as directed. Vitamin B2
(riboflavin) is not associated with any adverse or toxic effects
but it is important to note that in large doses it may turn the
urine yellowish-orange. Tell patients to take vitamin B3 (niacin) with milk or food to decrease GI upset. Niacin is often
used for dyslipidemia (see Chapter 28) and in much larger
doses. Vitamin B6 (pyridoxine) is more commonly used to
treat drug-induced B6 deficiencies. Two examples of this are
with the antituberculin drug isoniazid (INH) and the antihypertensive drug hydralazine hydrochloride. Vitamin B12
(cyanocobalamin) is administered orally with meals to
increase its absorption. Intranasal gel and sublingual tablets
are other dosage forms available. If given for megaloblastic
anemia, deep IM injection is the preferred route of administration. Give vitamin C (ascorbic acid) orally, and if an oral
effervescent form is used, instruct the patient to dissolve it in
at least 180 mL of water or juice. If vitamin C is administered
for acidification of urine, it is important for the nurse to frequently assess urinary pH.
Various oral calcium products are available and, because
of the differences in the amount of elemental calcium they
provide (e.g., calcium carbonate 1 250 mg is equal to only
500 mg of elemental calcium), medication errors may occur
and confusion may arise about the various dosages available
OTC. A list of the various calcium salts available is found
in Table 9.12. Instruct the patient to take oral dosage forms
of calcium 1 to 3 hours after meals. Injectable dosage forms
of calcium may also be confusing. Follow the medication
order carefully and check policies and standards regarding
infusions (see previous discussion in the pharmacology
section and the Preventing Medication Errors box below).
Because of problems with venous irritation, give intravenous calcium via an intravenous infusion pump and with
proper dilution. Giving intravenous calcium too rapidly
may precipitate severe hypercalcemia with subsequent heart
irregularities, delirium, and coma. Administer intravenous
calcium slowly, as ordered, and within the manufacturer
guidelines (e.g., usually less than 1 mL/min). Patients need
to remain recumbent for 15 minutes after the infusion to
prevent further problems. Should extravasation of the intravenous calcium solution occur, the nurse should discontinue the infusion immediately and leave the IV catheter
in place. The prescriber may then order an injection of 1%
procaine or other antidotes or fluids to reduce vasospasm at
the site and dilute the effects of the calcium on surrounding
tissue. However, follow all facility policies and procedural
guidelines and manufacturer insert information, as appropriate. In addition, include the appearance of the intravenous site (e.g., erythema, swelling, and any drainage) in the
documentation.
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PREVENTING MEDICATION ERRORS
All Calcium Forms Are Not the Same!
When calcium is given, it is essential to use the correct form. Calcium chloride has many uses, including treatment of cardiac arrest and hypocalcemic
tetany. Both calcium carbonate (Rolaids®, TUMS®) and calcium citrate
are used as antacids, and they are also used to treat or prevent calcium
deficiency. Be cautious when giving calcium—the different forms are not
interchangeable.
Administer magnesium according to manufacturer guidelines and as ordered. Always give intravenous magnesium sulphate cautiously; use an infusion pump, and follow manufacturer
guidelines for dosage and dilution concentration. During intravenous magnesium infusion, monitor the patient’s ECG and vital
signs, and rate patellar (knee-jerk) reflexes. Reduced reflexes are
used as an indication of drug-related CNS depressant effects.
Central nervous system depression may quickly lead to respiratory or cardiac depression; thus, perform frequent monitoring.
Document intravenous magnesium infusion and record each set
of vital sign measurements with ratings of reflexes. If there is a
decrease in the strength of reflexes or a decrease in respirations
to less than 10 breaths per minute, contact the prescriber immediately, stop the infusion, and monitor the patient. Other signs
that require immediate attention are confusion, irregular heart
rhythm, cramping, unusual fatigue, lightheadedness, and dizziness. Calcium gluconate must be readily accessible for use as an
antidote to magnesium toxicity. Administer oral dosage forms of
magnesium as ordered and in the exact dosage prescribed. See
the Patient Teaching Tips for more information concerning the
use of vitamins, minerals, and trace elements.
EVALUATION
In the patient’s evaluation, always review whether goals and outcome criteria have been met. Monitor for therapeutic responses
and adverse effects of each vitamin or mineral. Therapeutic
responses to vitamin A therapy include restoration of normal
vision and intact skin; adverse effects of vitamin A include
lethargy, headache, nausea, and vomiting (see Table 9.3).
Therapeutic responses to vitamin D include improved bone
growth and formation and an intact skeleton, with decreased
or no pain compared with baseline musculoskeletal deformity,
weakness, and discomfort; adverse effects include hypertension, dysrhythmias, fatigue, weakness, headache, and decreased
bone growth (see Table 9.4). Therapeutic responses to vitamin
E include improved muscle strength, improved skin integrity,
and α-tocopherol levels within normal limits; adverse effects are
listed in Table 9.5. Therapeutic responses to vitamin K include
return to normal clotting; adverse effects include headache,
nausea, and hemolytic anemia (see Table 9.6). Therapeutic
responses to vitamin B1 (thiamine) include improved mental
status and reduction in confusion. Therapeutic responses to
vitamin B2 (riboflavin) include improved skin integrity, normal
vision, improved mental status, and normal RBC, hemoglobin,
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PART 1 Pharmacology Basics
and hematocrit. Adverse effects from vitamin B3 (niacin) are
rare, but they are associated with postural hypotension, dysrhythmias, headache, and nausea (see Table 9.7 for complete
listing). Vitamin B6 (pyridoxine) adverse effects include flushing, paresthesias, lethargy, and headache. Vitamin B12 (cyanocobalamin) has the adverse effects of heart failure, flushing,
diarrhea, itching, and hypokalemia. Therapeutic responses to
vitamin C include improvements in capillary intactness, integrity of the skin and mucous membrane, healing, energy level,
and mental health state. Therapeutic responses to calcium
include improved deficiency states. Adverse effects are listed in
Table 9.13. Therapeutic effects of magnesium include bolstering
of many enzymatic functions in the body with other uses as an
anticonvulsant, treatment of pre-eclampsia and eclampsia, and
management of various dysrhythmias. Adverse effects include
loss of deep tendon reflexes, CNS depression, constipation,
respiratory distress, and heart block.
CASE STUDY
Vitamin Supplements
Brian, 49 years of age, was found unconscious in a vacant house and was brought to the emergency department. He had an
elevated blood alcohol level and eventually manifested delirium tremens. Now, a week later, he is in stable condition on a
medical–surgical unit. He is weak and malnourished, and he cannot remember how he got to the hospital. The nurse is
reviewing his medication list and notes that several vitamin supplements are ordered.
1. Based on Brian’s history, what vitamin deficiencies are possible?
2. Which vitamin supplement is especially used to treat complications associated with alcoholism? Explain your answer.
3. Brian is receiving large doses of several vitamins, and the nurse is concerned about vitamin toxicities. Which type of
vitamin, water-soluble or fat-soluble, carries the risk of toxicities? Explain your answer.
4. Because of Brian’s long-term malnourished state, the prescriber is concerned about the condition of his bones and starts Brian on phosphorus and calcium supplementation, along with vitamin D. Explain the rationale behind the addition of vitamin D.
For answers see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
PAT I E N T T E A C H I N G T I P S
• Educate the patient about the best dietary sources of both
water- and fat-soluble vitamins (vitamins A, B, C, D, E, and
K), as well as about the best sources of elements and minerals. See Table 9.2 for the nutrient content of select food items.
• Monitor any patient taking vitamins or minerals closely for
therapeutic and adverse effects. Encourage patients to monitor
self-progress on how well they feel and to note any improvement in the related condition or health status. Encourage
intake of fluids with all vitamin and mineral therapy.
• Inform patients who have had a gastrectomy or ileal resection and those with pernicious anemia of the necessity for
vitamin B12 injections. In the community, an oral supplementation may be used.
• Educate the patient taking up to
mg day of vitamin C
that there may be a slight increase in daily urination and that
diarrhea is associated with intake of more than 1 g of vitamin
C per day.
• Stress that patients taking calcium therapy and magnesium
(see Table 9.10) must take the medication as prescribed and
with adequate amounts of fluids.
• Educate the patient about calcium therapy and about food
items and drugs that will chelate (or bind) with calcium. For
example, calcium binds with tetracycline antibiotics and
decreases or negates the effect of the antibiotic.
KEY POINTS
•
ver the counter use of vitamins and minerals may lead to
serious problems and adverse effects and requires careful
consideration prior to self-medication. A health care provider may be consulted prior to use if there are any questions
or concerns.
• Incorporate the nutritional status of the patient into the collaborative plan of care to provide comprehensive care during
vitamin or mineral therapy.
• Provide information about dietary needs and the body’s need
for vitamins and minerals as part of the patient’s health promotion.
•
ocus patient education regarding vitamin and mineral
replacement on dietary sources of the specific nutrient,
drug and food interactions, and adverse effects. Instruct the
patient on when it is necessary to contact the health care provider.
• itamins and minerals can be dangerous to the patient if
given without concern or caution for the patient’s overall
condition and underlying disease processes.
• ever assume that because the drug is a vitamin or mineral
it does not have adverse reactions or toxicity.
CHAPTER 9 Vitamins and Minerals
131
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. The nurse is administering prescribed calcium to a patient
intravenously. hich of the following adverse events should
the nurse monitor for if calcium is given too fast?
a. Ototoxicity
b. Kidney damage
c. Tetany
d. Cardiac dysrhythmias
2. The nurse is to administer vitamin K to a client. hich of
the following laboratory tests should the nurse assess prior
to administration?
a. Prothrombin time and INR
b. Red blood cell and white blood cell counts
c. Phosphorus and calcium levels
d. Total protein and albumin levels
3. The nurse is caring for a patient who has gastrointestinal
malabsorption. hich of the following vitamin de ciencies
will the nurse monitor in the patient?
a. Vitamin A (retinol)
b. Vitamin B12 (cyanocobalamin)
c. Vitamin B6 (pyridoxine)
d. Vitamin E (tocopherols)
4. The nurse is performing wound care for a patient with a stage
I pressure ulcer. hich of the following supplements would
the nurse understand could assist with wound healing?
a. Vitamin K
b. Vitamin B1
c. Zinc
d. Calcium
5. The nurse is caring for a client with a history of alcoholism.
hich of the following vitamins would the nurse expect to
be ordered for this patient?
a. Vitamin B1 (thiamine)
b. Vitamin B6 (pyridoxine)
c. Vitamin C (ascorbic acid)
d. Vitamin A (retinol)
6. The nurse is to administer prescribed vitamin and mineral
supplements. hich of the following nursing interventions
would be most appropriate during administration of these
medications? (Select all that apply.)
a. Not administering oral calcium tablets along with oral
tetracyclines
b. Administering intravenous calcium via a rapid intravenous push infusion
c. Monitoring the heart rhythm (ECG) of a patient receiving
an intravenous magnesium infusion
d. Giving oral niacin with milk or food to decrease gastrointestinal upset
e. Monitoring for the formation of kidney stones in patients
taking large doses of vitamin C
7. The order reads, “Give vitamin K 0.5 mg IM within 1 hour
of birth.” The medication is available in a vial that contains 1
mg/0.5 mL. How many millilitres will the nurse draw up for
the injection?
8. The nurse is assessing a patient who has been recently admitted to the hospital after living on the streets for over 1 year.
The nurse notes that the patient has severely chapped and fissured lips. This could be a sign of which vitamin deficiency?
a. Vitamin B2 (riboflavin)
b. Vitamin B6 (pyridoxine)
c. Vitamin C (ascorbic acid)
d. Vitamin E (tocopherols)
CRITICAL THINKING ACTIVITIES
1. The nurse is about to administer calcium supplemental therapy to a patient with a history of cardiac disease. hat is the
most important assessment needed before the nurse gives
the drug?
2. A patient with a stage III pressure ulcer is receiving daily
doses of vitamin C and zinc. A new nurse asks the medication nurse
hy is this patient receiving these two particular supplements
hat is the nurse’s best answer
3. A patient receiving a magnesium infusion has developed
tendon reflex loss, CNS depression, and some respiratory
distress. These problems are a result of what condition
hat
are the nurse’s priority actions at this time?
For answers see http://evolve.elsevier.com/Lilley/pharmacology/.
e-LEARNING ACTIVITIES
•
•
•
•
Website
http://evolve.elsevier.com/Canada/Lilley/pharmacology/
• Answer Key—Textbook Case Studies
Answer Key—Critical Thinking Activities
Chapter Summaries—Printable
Review Questions for Exam Preparation
Unfolding Case Studies
132
PART 1 Pharmacology Basics
REFERENCES
Chan, T. H. (2015). Vitamin E and health. Retrieved from http://www.
hsph.harvard.edu/nutritionsource/vitamin-e/.
Health Canada. (2013). Dietary reference intakes. Retrieved from
http://www.hc-sc.gc.ca/fn-an/nutrition/reference/index-eng.php.
Health Canada. (2019a). Health Canada food guide. Retrieved from
https://food-guide.canada.ca/en/.
Health Canada. (2019b). Listing of monographs. Retrieved from http://
webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=eng.
Health Canada. (2019c). Vitamin D and calcium: Updated dietary
reference intakes. Retrieved from https://www.canada.ca/en/
health-canada/services/food-nutrition/healthy-eating/vitamins-minerals/vitamin-calcium-updated-dietary-reference-intakes-nutrition.html#a8a.
Rosenbloom, M. (2014). Vitamin toxicity. Retrieved from http://
emedicine.medscape.com/article/819426-overview.
The Heart and Stroke Foundation. (2019). Dietary fats, oils and cholesterol. Retrieved from https://www.heartandstroke.ca/get-healthy/
healthy-eating/fats-and-oils.
10
Principles of Drug Administration
PREPARING FOR DRUG ADMINISTRATION
NOTE: This chapter is designed to illustrate general aspects of
drug administration. For detailed instructions, please refer to a
nursing fundamentals or skills book.
When giving medications, remember safety measures and
correct administration techniques to avoid errors and to ensure
optimal drug actions. Keep in mind the following key Rights for
drug administration:
1. Right drug
2. Right dose
3. Right time
4. Right route
5. Right patient
6. Right reason
Refer to Chapter 1 for additional Rights 7-10 (Box 1.3). It
is important to note that health care professionals must adhere
to medication administration Rights as per each province and
territory’s professional regulatory body. Other things to keep in
mind when preparing to give medications are as follows:
• Remember to perform hand hygiene before preparing or giving medications (see Box 10.1).
• If unsure about a drug or dosage calculation do not hesitate
to double-check with a drug reference or pharmacist. DO
NOT give a medication if you are unsure about it!
• e punctual when giving drugs. Some medications must be
given at regular intervals to maintain therapeutic blood levels.
• There are a variety of automated dispensing machines—
decentrali ed medication distribution systems—that provide computer-controlled storage, dispensing, and tracking
of medications. Figure 10.1 shows one example of a computer-controlled drug-dispensing system. To prevent errors,
obtain the drugs for one patient at a time.
• Remember to check the drug at least three times before giving it. The first check is when the medications are removed
from the automated dispensing machine, the medication
drawer, or whatever system is in place at a given institution. The nurse is responsible for checking medication labels
against the transcribed medication order. In Figure 10.2, the
nurse is checking the drug against the medication administration record (MAR), after removing the drug from the
dispenser drawer. The second check is when preparing the
medications for administration. The drug should be checked
before opening the container, and again after opening it. It
is recommended that some drugs (e.g., heparin sulphate
and insulin must be checked by two licensed nurses. Some
agencies have specific policies regarding the two-nurse, double-check practice for certain medications. Always follow
agency policy. The final check occurs at the patient’s bedside,
just before medications are given. This check also provides
the opportunity to teach the patient about the medications.
BOX 10.1
Practices
Standard Precautions/Routine
Always adhere to standard precautions/routine practices, including the following:
• Wear clean gloves when there is exposure or potential exposure to blood,
body fluids, secretions, excretions, or any items that may contain these
substances. Always wash hands immediately when there is direct contact
with these substances or any item contaminated with blood, body fluids,
secretions, or excretions. Follow agency policy about wearing gloves when
giving injections and during medication preparation. Be sure to assess for
latex allergies and use nonlatex gloves if indicated.
• Perform hand hygiene after removing gloves and between patient contacts.
According to the World Health Organization (2009) and Centers for Disease
Control and Prevention, the preferred method of hand decontamination is
with an alcohol-based hand rub, but washing with an antimicrobial soap
and water is an alternative to the alcohol rub. Use soap and water to wash
hands when they are visibly dirty or visibly soiled with blood or other body
fluids and after using the toilet.
• Perform hand hygiene in the following circumstances:
• Before direct contact with patients
• After contact with blood, body fluids, excretions, mucous membranes,
wound dressings, or nonintact skin
• After contact with a patient’s skin (e.g., when taking a pulse or positioning a patient)
• After removing gloves
• Wear a mask, eye protective gear, and a face shield during any procedure
or patient care activity with the potential for splashing or spraying of blood,
body fluids, secretions, or excretions. Use of a gown may also be indicated
for these situations.
• When administering medications, once the exposure or procedure is completed and exposure is no longer a danger, remove contaminated protective
garments or gear and perform hand hygiene.
• Never remove, cap, recap, bend, or break any used needle or needle system. Be sure to discard any disposable syringes and needles in the appropriate puncture-resistant container.
133
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PART 1 Pharmacology Basics
Fig. 10.3 Always check the patient’s identification and allergies
before giving medications.
Fig. 10.1 Mobile computer-controlled medication workstation.
Fig. 10.4 Example of a hospital bar code.
Fig. 10.2 Checking the medication against the order on the electronic medication administration record.
•
ealth care facilities have various means of checking the
MAR when a new one is printed, so be sure that you are
working from an MAR that has been checked or verified
before giving the oral medication. If the patient’s MAR has
a new drug order on it, the best rule of practice is to double-check that order against the original medication order on
the patient’s chart.
• Check the expiration date of all medications. Medications
used past the expiration date may be less potent or potentially harmful.
• Make sure that drugs that are given together are compatible.
For example, bile acid sequestrants and antacids (see Chapters 28 and 39) must not be given with other drugs because
they will interfere with drug absorption and action. Check
with a pharmacist if unsure.
• efore administering any medication check the patient’s
identification bracelet (Figure 10.3). If the patient is in an
isolation room, follow hospital policy regarding how to
check patient identification. Also assess the patient’s drug
allergies. Some hospitals use a bar code system shown in
Figure 10.4. Accreditation Canada standards require two
patient identifiers (name and birthday, or name and account
number, according to the facility policy). In some facilities,
patient information is in a bar code system that is scanned.
Advanced bar code technology allows the nurse to scan her
badge, the patient’s hospital identification band, and the
medication, to assure that the right patient is receiving the
correct medication in the correct dose and by the correct
route.
• Assess the patient’s physical condition prior to administering a medication. This may be focused on a specific system
or value (e.g., plasma glucose level prior to the administration of insulin, blood pressure and heart rate prior to the
administration of an antihypertensive, or a pain assessment
prior to administering an analgesic). The prescriber may
provide certain parameters for when to administer or withhold a medication. This assessment provides a baseline for
post-medication evaluation.
• In addition assess the patient’s drug allergies before giving
any medication. Be aware of medications that may have
adverse effects, such as mental status changes or bronchospasm.
CHAPTER 10 Principles of Drug Administration
135
Fig. 10.6 Some medications require special assessment before
administration, such as measuring the apical pulse rate. (Shutterstock.)
the drug route. For example, responses to sublingual nitroglycerin or intravenous push medications need to be evaluated within minutes, but it may take an hour or more for a
response to be noted after an oral medication is given.
• See Special Populations Children Pharmacokinetic Changes
in Children box in Chapter 4 for age-related considerations
when administering medication to infants and children.
ENTERAL DRUGS
Fig. 10.5 One example of a medication administration record
(MAR). (Courtesy Princess Margaret Hospital, Toronto, ON.)
•
•
•
•
•
•
•
e sure to take the time to explain to the patient and caregiver the purpose of each medication, its action, possible
adverse effects, and any other pertinent information, especially drug–drug or drug–food interactions.
pen the medication at the bedside into the patient’s hand
or into a medicine cup. Try not to touch the drugs with your
hands. Leaving the drugs in their packaging until you get to
the patient’s room helps to avoid contamination and waste in
case the patient refuses the drug.
If the patient refuses a drug the drug may be returned to the
automated medication dispenser or to the pharmacy if the
package is unopened. Check facility policy. Discard opened
drugs per facility protocol. Scheduled drugs that are not
given will need a witness if discarded. Note on the patient’s
record which drug was refused and the patient’s reason for
refusal.
iscard any medications that fall to the oor or become contaminated by other means.
Remain with the patient while the patient takes the drugs.
Do not leave the drugs on the bedside table or the meal tray
for the patient to take later.
Chart the medication on the MAR as soon as it is given and
before going to the next patient (Figure 10.5). Be sure to also
document therapeutic responses, adverse effects (if any), and
other concerns in the nurse’s notes. Some facilities use manual documentation, and others use electronic documentation.
Return to evaluate the patient’s response to the drug. Remember that the expected response time will vary according to
Administering Oral Drugs
Always begin by washing your hands and maintain standard precautions/routine practices (see Box 10.1). When administering
oral drugs, keep in mind the points outlined in the sections below.
Oral Medications
• Administration of some oral medications and medications by other routes) requires special assessments. For
example, it is recommended that the apical pulse be auscultated for 1 full minute before any digitalis preparation
is given (Figure 10.6). Administration of other oral medications may require blood pressure monitoring. Be sure
to document all parameters on the MAR. In addition, do
not forget to check the patient’s identification and allergies before giving any oral medication (or medication by
any other route).
• If the patient is experiencing di culty swallowing dysphagia), some types of tablets can be crushed with a pill-crushing device (Figure 10.7) for easier administration. Crush one
type of pill at a time, because if you mix together all the medications before crushing (instead of crushing them one at a
time) and then spill some, there is no way to tell which drug
has been wasted. Also, if all are mixed together, you cannot
check the Five Rights three times before giving the drug. Mix
the crushed medication in a small amount of soft food, such
as applesauce or pudding. Be sure that the entire serving is
consumed, and the pill-crushing device is clean before and
a er you use it. See Chapter 2 for more information on medications that should not be crushed.
• CAUTI
e sure to verify whether a medication can be
crushed by consulting a drug reference book or a pharmacist. Some oral medications such as capsules enteric coated
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PART 1 Pharmacology Basics
Fig. 10.9 Giving oral medications.
Fig. 10.7 Using a pill-crushing device to crush a tablet. (From Perry,
A. G., & Potter, P. A. (2010). Clinical nursing skills and techniques (7th
ed.). St. Louis, MO: Mosby.)
Fig. 10.10 Proper placement of a sublingual tablet. (From Rick Brady,
Riva, MD.)
Fig. 10.8 Enteric-coated tablets and long-acting medications should
not be crushed. (From Rick Brady, Riva, MD.)
tablets, and sustained-release or long-acting drugs, must not
be crushed, broken, or chewed (Figure 10.8). These medications are formulated to protect the gastric lining from
irritation or to protect the drug from destruction from gastric acids or are designed to break down gradually to slowly
release the medication. If these drugs, designated with labels
such as sustained-release or extended-release, are crushed
or opened, then the intended action of the dosage form is
destroyed. As a result, gastric irritation may occur, the drug
may be inactivated by gastric acids, or the immediate availability of a drug that was supposed to be released slowly may
cause toxic effects. Check with the health care provider or
pharmacist to see if an alternate form of the drug is needed.
• e sure to position the patient in a sitting or side lying position to make it easier to swallow oral medications and to
avoid the risk of aspiration (Figure 10.9). Always provide
aspiration prevention measures as needed.
•
er the patient a full glass of water
to
m of water
or other uid is recommended for the best dissolution and
absorption of oral medications.
• Age related and uid restricted considerations Children and
older adults may not be able to drink a full glass of water but
need to take enough uid to ensure that the medication reaches
the stomach. If the patient prefers another uid be sure to check
•
•
•
•
•
for interactions between the medication and the uid of choice.
If uid restriction is ordered be sure to follow the guidelines.
If the patient requests it you may place the pill or capsule in
his or her mouth with your gloved hand.
o enges are not chewed unless this instruction is speci cally given.
E ervescent powders and tablets should be mixed with water
and then given immediately after they are dissolved.
Remain with the patient until all medication has been swallowed. If you are unsure whether a pill has been swallowed,
ask the patient to open his or her mouth so that you can
inspect to see if it is gone. Assist the patient to a comfortable
position after the medication has been taken.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Sublingual and Buccal Medications
The sublingual and buccal routes prevent destruction of the drugs
in the gastrointestinal tract and allow for rapid absorption into the
bloodstream through the oral mucous membranes. Be sure to provide instruction to the patient before giving these medications.
• Sublingual tablets are placed under the tongue Figure
10.10). Buccal tablets are placed between the upper or lower
molar teeth and the cheek.
CHAPTER 10 Principles of Drug Administration
Fig. 10.11 A, Liquid medication in a unit-dose package. B, Liquid
measured into a medicine cup from a multidose container. C, Liquid medicine in an oral-dosing syringe. (From Elkin, M. K., Perry, A.
G., & Potter, P. A. (2012). Nursing interventions and clinical skills (5th
ed.). St. Louis, MO: Mosby.)
•
•
•
•
•
•
e sure to wear gloves if you are placing the tablet into the
patient’s mouth. Adhere to standard precautions/routine
practices (see Box 10.1).
Instruct the patient to allow the drug to dissolve completely
and not to swallow it.
These drug forms are not taken with uids. Instruct the
patient not to drink anything until after the tablet has dissolved completely.
e sure to instruct the patient not to swallow the tablet saliva
should also not be swallowed until after the drug is dissolved.
hen using the buccal route alternate sides with each dose
to reduce possible oral mucosal irritation.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Liquid Medications
• iquid medications may be packaged as a single dose unit
dose) package, be poured into a medicine cup from a multidose bottle, or be drawn up in an oral-dosing syringe (Figure
10.11).
•
hen pouring a liquid medication from a container rst
shake the bottle gently to mix the contents, if indicated.
Remove the cap and place it on a paper towel on the counter,
upside down. old the bottle with the label against the palm
of your hand to keep any spilled medication from altering
the label. Place the medicine cup at eye level and ll to the
proper level on the scale (Figure 10.12 . Pour the liquid so
that the base of the meniscus is even with the appropriate
line measure on the medicine cup.
• If you over ll the medicine cup discard the excess in an
environmentally appropriate way according to agency policy. Do not pour it back into the multidose bottle. Before
replacing the cap, wipe the rim of the bottle with a paper
towel.
•
oses of medications that are less than m cannot be
measured accurately in a calibrated medicine cup. For small
volumes, use a calibrated syringe. Do not use a hypodermic
137
Fig. 10.12 Measuring liquid medication at eye level. (From Rick
Brady, Riva, MD.)
syringe or a syringe with a needle or syringe cap. If hypodermic syringes are used, the drug may be inadvertently given
parenterally, or the syringe cap or needle, if not removed
from the syringe, may become dislodged and accidentally
aspirated by the patient when the syringe plunger is pressed.
•
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Oral Medications for Infants and Children
• iquids are usually ordered for infants and young children
because they cannot swallow oral pills or capsules.
• A plastic disposable oral dosing syringe is recommended
for measuring small doses of liquid medications. Use of
an oral-dosing syringe prevents the inadvertent parenteral administration of a drug once it is drawn up into the
syringe.
• Position the infant so that the head is slightly elevated to
prevent aspiration. Not all infants will be cooperative, and
many may need to be partially restrained (Figure 10.13).
• Place the plastic dropper or syringe inside the infant’s
mouth, beside the tongue, and administer the liquid in
small amounts while allowing the infant to swallow each
time.
• A clean empty nipple may be used to administer the medication. Place the liquid inside the empty nipple and allow
the infant to suck the nipple. Add a few millilitres of water
to rinse any remaining medication into the infant’s mouth,
unless contraindicated.
• Take great care to prevent aspiration. A crying infant can easily aspirate medication. If the infant is crying, wait until the
infant is calmer before trying again to give the medication.
•
o not add medication to a bottle of formula the infant may
refuse the feeding or may not drink all of it.
• Make sure that all of the oral medication has been taken and
then return the infant to a safe, comfortable position.
•
ever use honey on infants who re ect bitter tasting oral
medications. oney is not recommended because of the risk
of botulism.
138
PART 1 Pharmacology Basics
Fig. 10.13 Administering oral liquid medication to an infant. (Courtesy Oscar H. Allison, Jr. (2010). In Clayton, B. D., & Stock, Y. N. (Eds.).
Basic pharmacology for nurses (15th ed.). St. Louis, MO: Mosby.)
• If infants or children re ect oral medications that taste bitter, the drug may be mixed with 5 mL (1 teaspoon) of a
sweet-tasting food such as jelly, applesauce, ice cream, or
sherbet. Do not mix the medication in an essential food item,
such as formula, milk, or orange juice, because the child may
reject that food later. After the medication is taken, offer the
child diluted uice a avoured fro en popsicle or water.
Fig. 10.14 Check the gastric residual before administering medications.
Administering Drugs Through a Nasogastric or
Gastrostomy Tube
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Follow
agency policy about wearing gloves during the procedure.
When administering drugs via these routes, keep in mind the
following points:
• ollow institution speci c protocols for medication administration through a nasogastric (NG) or gastrostomy tube.
Institutions may require checking the placement of the NG
tube and assessing gastric residual volumes (how much of
the previous feeding is in the stomach). Reinstill gastric
residual per institutional policy, and then clamp the tube
(Figure 10.14).
• efore giving drugs via these routes position the patient in a
semi-Fowler’s or high Fowler’s position and leave the head of
the bed elevated for at least 30 minutes afterward, to reduce
the risk of aspiration (Figure 10.15).
• Assess whether uid restriction or uid overload is a concern. It will be necessary to give water along with the medications to ush the tubing.
• Check to see if the drug is recommended to be given on an
empty or full stomach. In addition, some drugs are incompatible with enteral feedings. If the drug is to be taken on an
empty stomach, or if incompatibility exists, the feeding may
need to be stopped before and after giving the medication.
Follow the guidelines for the specific drug if this is necessary.
Fig. 10.15 Elevate the head of the bed before administering medications through a nasogastric tube.
Examples of drugs that are not compatible with enteral feedings are phenytoin and carbidopa-levodopa. Whenever possible, give liquid forms of the drugs to prevent clogging of the
tube.
• If tablets must be given crush them individually into a ne
powder. Administer the drugs separately (Figure 10.16).
Keeping the drugs separate allows for accurate identification
if a dose is spilled. Be sure to check whether the medication
can be crushed in general do not administer sustained release, chewable, long-acting, or enteric-coated tablets or
capsules through an NG or gastrostomy tube. Check with a
pharmacist if you are unsure.
CHAPTER 10 Principles of Drug Administration
Fig. 10.16 Medications given through gastric tubes should be
administered separately. Dilute crushed pills in 15 to 30 mL of
water before administration. (From Rick Brady, Riva, MD.)
139
Fig. 10.18 Lubricate the suppository with a water-soluble lubricant.
•
•
•
•
restrictions are ordered but su cient uid must be used to
dilute the medication and to ush the tubing.
If water or medication does not ow freely you may apply
gentle pressure with the plunger of the syringe or the bulb
of the syringe. Do not try to force the medicine through the
tubing.
A er the last drug dose ush the tubing with m of warm
water, and then clamp the tube. Resume the tube feeding
when appropriate.
ave the patient remain in a high owler’s or slightly elevated right–side-lying position to reduce the risk of aspiration.
ocument the medications given on the MAR see Figure
10.5 the amount of uid given on the patient’s intake and
output record, and the patient’s response in the patient’s
record.
Administering Rectal Drugs
Fig. 10.17 Pour liquid medication into the syringe. Then unclamp
the tubing and allow it to flow in by gravity.
•
ilute a crushed tablet or liquid medication in
to
m
of warm water. Some capsules may be opened and dissolved
in m of warm water check with a pharmacist.
• Remove the piston from an adaptable tip syringe and attach
it to the end of the tube. Unclamp the tube and pinch the tubing to close it again. Add 30 mL of warm water and release
the pinched tubing. Allow the water to ow in by gravity to
ush the tube and then pinch the tubing closed again before
all the water is gone to prevent excessive air from entering
the stomach. If a stopcock valve device is present on the
enteral tube, open and close the stopcock instead of pinching
the tubing to clamp it.
• Pour the diluted medication into the syringe and release the
tubing to allow it to ow in by gravity Figure 10.17). Flush
between each drug with 10 mL of warm water. Be careful not
to spill the medication mixture. Ad ust uid amounts if uid
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves must
be worn. When administering rectal drugs, keep in mind the
following points:
• Assess the patient for the presence of active rectal bleeding or
diarrhea, which generally are contraindications for the use of
rectal suppositories.
• Suppositories should not be divided to provide a smaller
dose. The active drug may not be evenly distributed within
the suppository base.
• Position the patient on the le side unless contraindicated.
The uppermost leg needs to be exed toward the waist Sims’
position . Provide privacy and drape.
•
o not insert the suppository into stool. ently palpate the
rectal wall for presence of feces. If possible, have the patient
defecate. DO NOT palpate the patient’s rectum if the patient
has had rectal surgery.
• Remove the wrapping from the suppository and lubricate the
rounded tip with water-soluble gel (Figure 10.18).
• Insert the tip of the suppository into the rectum while having
the patient take a deep breath and exhale through the mouth.
With your gloved finger, quickly and gently insert the suppository into the rectum, alongside the rectal wall, at least 2.5
cm beyond the internal sphincter (Figure 10.19).
140
PART 1 Pharmacology Basics
Fig. 10.19 Inserting a rectal suppository. (From Perry, A. G., & Potter,
P. A. (2010). Clinical nursing skills and techniques (7th ed.). St. Louis,
MO: Mosby.)
Fig. 10.21 Vaginal cream and suppository, with applicators. (From
Rick Brady, Riva, MD.)
Fig. 10.20 Vaginal suppositories (right) are larger and more oval
than rectal suppositories (left). (From Rick Brady, Riva, MD.)
•
•
•
•
•
ave the patient remain lying on the le side for
to
minutes to allow absorption of the medication.
Age related considerations ith children it may be necessary to gently but firmly hold the buttocks in place for 5 to 10
minutes until the urge to expel the suppository has passed.
Older adults with loss of sphincter control may not be able to
retain the suppository.
If the patient prefers to self administer the suppository give
specific instructions on its purpose and correct procedure.
Be sure to tell the patient to remove the wrapper.
Use the same procedure for medications administered by a
retention enema, such as sodium polystyrene sulfonate (see
Chapter 40). Drugs given by enemas are diluted in the smallest amount of solution possible. Retention enemas need to
be held for 30 minutes to 1 hour before expulsion, if possible,
for maximum absorption.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Administering Vaginal Medications
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves must
be worn. When administering vaginal preparations, keep in
mind the following points:
• aginal suppositories are larger and more oval than rectal
suppositories (Figure 10.20).
• Figure 10.21 shows examples of a vaginal suppository in its
applicator and vaginal cream in an applicator.
• efore giving these medications explain the procedure to
the patient, have her void to empty the bladder, and perform
pericare.
• If possible administer vaginal preparations at bedtime to
allow the medications to remain in place for as long as possible.
• Some patients may prefer to self administer vaginal medications. Provide speci c instructions if necessary.
• Position the patient in the lithotomy position and elevate the
hips with a pillow, if tolerated. Be sure to drape the patient to
provide privacy.
Creams, Foams, or Gels Applied With an Applicator
•
it the applicator to the tube of the medication and then
gently squeeze the tube to fill the applicator with the correct
amount of medication.
• ubricate the tip of the applicator with a water soluble lubricant.
• Use your nondominant hand to spread the labia and expose
the vagina. Gently insert the applicator as far as possible into
the vagina (Figure 10.22).
• Push the plunger to deposit the medication. Remove the
applicator and wrap it in a paper towel for cleaning.
Suppositories or Vaginal Tablets
• or suppositories or vaginal tablets remove the wrapping
and lubricate the suppository with a water-soluble lubricant.
Be sure that the suppository is at room temperature.
• Using the applicator insert the suppository or tablet into the
vagina, and then push the plunger to deposit the suppository.
Remove the applicator.
• If no applicator is available use your dominant index nger
to insert the suppository about 5 cm into the vagina (Figure
10.23).
•
ave the patient remain in the supine position with hips elevated for 5 to 10 minutes to allow the suppository to dissolve
and the medication to absorb.
• If the patient desires apply a perineal pad.
• If the applicator is to be reused wash with soap and water
and store in a clean container for the next use.
CHAPTER 10 Principles of Drug Administration
141
Vagina
Rectum
Fig. 10.22 Administering vaginal cream with an applicator. (From
Elkin, M. K., Perry, A. G., & Potter, P. A. (2004). Nursing interventions
and clinical skills (3rd ed.). St. Louis, MO: Mosby.)
Fig. 10.24 NEVER RECAP A USED NEEDLE! Always dispose of
uncapped needles in the appropriate sharps container. Refer to Box
10-1 for standard precautions/routine practices. (From Rick Brady,
Riva, MD.)
Vagina
Rectum
Fig. 10.23 Administering a vaginal suppository. (From Elkin, M. K.,
Perry, A. G., & Potter, P. A. (2004). Nursing interventions and clinical
skills (3rd ed.). St. Louis, MO: Mosby.)
Fig. 10.25 An UNUSED needle may need to be recapped before the
medication is given to the patient. The “scoop method” is one way
to recap an unused needle safely. Be sure not to touch the needle
to the countertop or to the outside of the needle cap.
Preparing for Parenteral Drug Administration
•
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
PARENTERAL DRUGS
According to the orld ealth rgani ation
, gloves are
not usually recommended for injections if the skin is intact.
loves do not protect against a needle stick in ury. Practice
may vary among institutions/agencies and educational settings
about the use of gloves to prepare and administer parenteral
drugs. or the purpose of this text the images re ect the use of
gloves to prepare and administer parenteral drugs. It is always
recommended to follow the agency policy.
Figures 10.24 through 10.34 show equipment used for administering parenteral drugs.
Removing Medications from Ampoules
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn, especially if the medication is toxic. When performing
these procedures, keep in mind the following points:
• Medication o en rests in the top part of the ampoule. Tap the
top of the ampoule lightly and quickly with your finger until
all uid moves to the bottom portion of the ampoule see
Figure 10.35).
•
hen removing medication from an ampoule use a sterile
filter needle, if available (see Figure 10.34). These needles
142
PART 1 Pharmacology Basics
5 mL syringe
3 cc syringe
1 cc tuberculin syringe
Low-dose insulin syringe
Fig. 10.26 Examples of several different types of needle-stick prevention syringes. (Courtesy Becton, Dickinson and Company.)
Fig. 10.29 Be sure to choose the correct size and type of syringe for
the drug ordered. (From Potter, P. A., Perry, A. G., Stockert, P. A., et al.
(2011). Basic Nursing (7th ed.). St. Louis, MO: Mosby.)
Bevel
Tip
Needle cap
Plunger
Shaft
Hub
18 g
22 g
21 g
20 g
22 g
23 g
25 g
25 g
38.2 mm 38.2 mm 25.4 mm 25.4 mm 25.4 mm 0.6 mm 0.55 mm 38.2 mm
Barrel
Fig. 10.27 The parts of a syringe and hypodermic needle. (Courtesy
Chuck Dresner.)
Fig. 10.30 Needles come in various gauges and lengths. The larger
the gauge, the smaller the needle and often the shorter in length.
Be sure to choose the correct needle—gauge and length—for the
type of injection ordered. (From Rick Brady, Riva, MD.)
Bevel
Fig. 10.28 Close-up view of the bevel of a needle. (Courtesy Chuck
Dresner.)
Figs. 10.31 and 10.32 Figure 10.31 is an example of prefilled low-molecular-weight heparin enoxaparin sodium. Figure 10.32 is an example of a saline lock prefilled syringe. After use, the syringe is disposed
of in a sharps container. (For Figure 10.31: courtesy of Sandoz Novartis.)
(For Figure 10.32: courtesy of Hospira Healthcare Corporation.)
CHAPTER 10 Principles of Drug Administration
143
Fig. 10.36 Breaking an ampule. Carefully break the neck of the
ampule in a direction away from you and away from others near
you. (From [A] and [B] from Rick Brady, Riva, MD.)
Fig. 10.33 Ampoules containing medications come in various sizes.
The neck of the ampoule must be broken carefully before the medication is withdrawn. (From Potter, P. A., & Perry, A. G. (2001). Fundamentals of nursing (5th ed.). St. Louis, MO: Mosby.)
Fig. 10.34 Use a filter needle when withdrawing medication from
an ampoule. Filter needles help remove tiny glass particles that
may result from breaking the ampoule. DO NOT USE A FILTER
NEEDLE for injecting medication into a patient! Some institutions
may also require the use of a filter needle to withdraw medications
from a vial. (From Rick Brady, Riva, MD.)
Fig. 10.35 Tapping an ampoule to move the fluid below the neck.
(From Rick Brady, Riva, MD.)
Fig. 10.37 Using a filter needle to draw medication from an
ampoule. (From Rick Brady, Riva, MD.)
are designed to filter out glass particles that may be present inside the ampoule a er it is broken. The lter needle IS
NOT intended for administration of the drug to the patient.
• Place a small gau e pad or dry alcohol swab around the neck of
the ampoule to protect your hand. Snap the neck quickly and
firmly and break the ampoule away from your body and away
from any other open areas or individuals (Figure 10.36). There
are many varieties of ampoule breakers that are available to
open ampoules and minimize the risk of potential injury from
broken edges of glass. Many agencies also use a plastic sleeve
that is placed over the neck of the ampoule. The ampoule is
broken in the same manner as described above.
• To draw up the medication either set the open ampoule on a
at surface or hold the ampoule upside down. Insert the lter
needle (attached to a syringe) into the centre of the ampoule
opening. Do not allow the needle tip or shaft to touch the rim
of the ampoule (Figure 10.37).
144
•
•
•
•
•
•
PART 1 Pharmacology Basics
ently pull back on the plunger to draw up the medication.
Keep the needle tip below the uid within the vial tip the
ampoule to bring all of the uid within reach of the needle.
Avoid touching the inside of the plunger when pulling it
back.
If air bubbles are aspirated do not expel them into the
ampoule. Remove the needle from the ampoule, hold the
syringe with the needle pointing up, and tap the side of the
syringe with your finger to cause the bubbles to rise toward
the needle. Draw back slightly on the plunger, and slowly
push the plunger upward to e ect the air. o not e ect uid.
Excess medication is disposed of into the sink. old the
syringe vertically with needle tip up and slanted toward the
sink. Slowly e ect the excess uid into the sink and then
recheck the uid level by holding the syringe vertically.
Remove the lter needle and replace with the appropriate
needle for administration. E ER use a lter needle to
administer medications to a patient!
e sure to ensure the sterility of the in ection needle throughout the process. Do not touch the open end of the needle
hub, or the tip of the syringe, when attaching a needle to a
syringe.
ispose of the glass ampoule pieces and the used lter needle
into the appropriate sharps container.
Removing Medications from Vials
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn. When performing these procedures, keep in mind the
following points:
• ials can contain either a single dose or multiple doses of
medications. Follow the institution’s policy for using opened
multidose vials, such as vials of insulin. Mark multidose
vials with the date and time of opening and the discard date
(per institution policy). If you are unsure about the age of an
opened vial of medication, discard it and obtain a new one.
• Check institutional policies regarding which type of needle
to use to withdraw uid from a vial.
•
ith the exception of insulin which must be withdrawn
using an insulin syringe uid may be withdrawn from a vial
using a blunt ll needle or a lter needle. Using a blunt ll
needle reduces the chance of injury.
• If the vial is unused remove the cap from the top of the vial
and clean well with an alcohol swab.
• If the vial has been previously opened and used wipe the top
of the vial vigorously with an alcohol swab.
• Air must rst be in ected into a vial before uid can be withdrawn. The amount of air injected into a vial needs to equal
the amount of uid to be withdrawn.
•
etermine the volume of uid to be withdrawn from the
vial. Pull back on the syringe’s plunger to draw an amount of
air into the syringe that is equivalent to the volume of medication to be removed from the vial (Figure 10.38). Insert the
syringe into the vial, preferably using a needleless system.
• Some vials are not compatible with needleless systems and
therefore require a needle for uid withdrawals. Use a blunt
fill needle, if possible.
Figs. 10.38 and 10.39 Inject air into the vial before withdrawing
medication (needleless system shown). Needleless vial adaptor
shows a needleless system of vial access. (For Figure 10.38: from
Rick Brady, Riva, MD.) (For Figure 10.39: courtesy of Healthmark Services Canada.)
Figs. 10.40 and 10.41 Using a needle and syringe to remove medication from a vial (needleless system shown on the right).
• Figure 10.39 shows a needleless vial adaptor that may be
used for safe and rapid transfer and reconstitution of drugs
between vials and syringes. It can be used for a multidose
vial. Adaptors are available in a variety of styles. Many have
a blunt access device. Adaptors were created to reduce exposure to needle-stick injuries. To use the adaptor, remove the
cover from the vial cap on a rm surface centre the needless
adaptor directly over the top of the vial and press the adaptor firmly onto the vial until it is sealed. The adaptor can be
cleansed with an alcohol wipe and the drug removed similarly to the steps described below.
•
hile holding onto the plunger invert the vial and remove
the desired amount of medication (Figure 10.40 and Figure 10.41).
CHAPTER 10 Principles of Drug Administration
Intramuscular
90° 90°
Subcutaneous
45°
15°
Intradermal
Skin
Subcutaneous
tissue
Muscle
Fig. 10.42 Various needle angles. (Courtesy of Nadine Sokol.)
•
ently but rmly tap the syringe to remove air bubbles.
Excess uid if present should be discarded into a sink.
•
hen an in ection requires two medications from two different vials, begin by injecting air into the first vial (without
touching the uid in the rst vial and then in ect air into the
second vial. Immediately remove the desired dose from the
second vial. Change needles (if possible), and then remove
the exact prescribed dose of drug from the first vial. Take
great care not to contaminate the drug in one vial with the
drug from the other vial. Check with a pharmacist to make
sure the two drugs are compatible for mixing in the same
syringe.
• or in ections if a needle has been used to remove medication from a vial, always change the needle before administering the dose. Changing needles ensures that a clean and
sharp needle is used for the injection. It also avoids the risk
of irritation to the patient’s tissues caused by medication
remaining on the outside of the needle. In addition, the needle may become dull if used to puncture a rubber stopper.
owever some syringes such as insulin syringes have needles that are fixed onto the syringe and cannot be removed.
• Ensure the sterility of the in ection needle throughout the
process. Do not touch the open end of the needle hub, or the
tip of the syringe, when attaching a needle to a syringe.
Injections Overview
Current best practice for the administration of injections varies throughout health care agencies and practice environments
(Crawford & Johnson, 2012). Aspiration for intramuscular
in ections is one controversial topic—the literature is unclear as
to whether it is best practice to aspirate or not aspirate for blood
before medication injections. Evidence shows that no aspiration is required for the intramuscular injections of vaccines and
immunizations and subcutaneous injections of heparin sulphate and insulin (Centers for isease Control and Prevention
Crawford ohnson
).
Needle Insertion Angles for Intramuscular, Subcutaneous,
and Intradermal Injections
• or any in ection if syringes are prepared at a medication
cart or in a medication room, each parenteral medication
should be prepared separately and a label identifying the
patient, the medication, the dose, and the route placed on the
barrel of the syringe before the nurse leaves the preparation
area.
• or intramuscular IM in ections insert the needle at a
90-degree angle (see Figure 10.42). Intramuscular injections
deposit the drug deep into muscle tissue, where the drug is
145
absorbed through blood vessels within the muscle. The rate
of absorption of a drug given by the IM route is slower than
that of drugs given by the intravenous route but faster than
that of drugs given by the subcutaneous route. Intramuscular injections generally require a longer needle to reach the
muscle tissue, but shorter needles may be needed for older
patients, children, and adults who are malnourished. The site
chosen will also determine the length of the needle needed.
In general, aqueous drugs can be given with a 22- to 27-gauge
needle however oil based or more viscous thick drugs are
given with an 18- to 25-gauge needle. Average needle lengths
for children range from 16 mm to 25 mm, and needles for
adults range from 25 mm to 38 mm. The nurse must choose
the needle length based on the size of the muscle at the injection site, the age of the patient, and the type of drug used.
For a normal, well-developed adult, 3 mL is the maximum
amount used in a single injection. Follow agency policy. If
more than 3 mL is needed for the ordered dose, then the
drug will need to be given in two separate in ections. owever, if the patient is an older adult or thin, a smaller maximum volume, such as 2 mL, is recommended.
• or subcutaneous subcut in ections insert the needle at
either a
or a
degree angle. Subcutaneous in ections
deposit the drug into the loose connective tissue under the
dermis. This tissue is not as well supplied with blood vessels
as the muscle tissue is as a result drugs are absorbed more
slowly when given subcutaneously than when given intramuscularly. Doses are usually 0.5 to 1 mL. In general, use a
25-gauge, 12-mm to 16-mm needle (for insulin, a 6-mm or
8-mm needle is recommended). A 90-degree angle is used
for a patient of average si e a
degree angle may be used
for patients who are thin, emaciated, or cachectic and for
children. To ensure correct needle length, grasp the skin fold
with the thumb and forefinger, and choose a needle that is
approximately one half the length of the skin fold from top
to bottom.
• Intradermal I in ections are given into the outer layers
of the dermis in tiny amounts, usually 0.01 to 0.1 mL. These
injections are used mostly for diagnostic purposes, such as
when testing for allergies or tuberculosis and for local anaesthesia. Little of the drug is absorbed systemically. In general,
choose a tuberculin or 1-mL syringe with a 26- or 27-gauge
needle that is 10 mm to 16 mm long. The angle of injection is
5 to 15 degrees.
• or speci c information about giving in ections to children
see Box 10.2.
Air-Lock Technique
• Some facilities recommend administering IM in ections
using the air-lock technique (Figure 10.43). Check institutional policy.
• A er withdrawing the desired amount of drug into the
syringe, withdraw an additional 0.2 mL of air. Be sure to
inject using a 90-degree angle. The small air bubble that follows the medication during the injection may help prevent
the medication from leaking through the needle track into
the subcutaneous tissues.
146
PART 1 Pharmacology Basics
BOX 10.2
Pediatric Injections
For pediatric injections, site selection is crucial. Factors to consider are the
age of the child, the size of the muscle at the injection site, the type of injection, the thickness of the solution, and the ease with which the child can be
positioned properly. There is no universal agreement in the literature on the
best intramuscular injection site for children. For infants, the preferred site is
the vastus lateralis muscle. The ventrogluteal site may also be used in children
of all ages. For immunizations in toddlers and older children, the deltoid muscle may be used if the muscle mass is well developed. Intramuscular injections
for older infants and small children should not exceed 1 mL in a single injection. Refer to facility policy.
Children are often extremely fearful of needles and injections. Even a child
who appears calm may become upset and lose control during an injection
procedure. For safety reasons, it is important to have another person available
for positioning and holding the child.
Distraction techniques are helpful. Say to the child, “If you feel this you can
ask me to take it out, please.” Be quick and efficient when giving the injection.
Have a small, colourful adhesive bandage on hand to apply after the injection. If the child is old enough, have the child hold the bandage and apply it
after the injection. If possible, offer a reward sticker after the injection.
After the injection, allow the child to express feelings about the injection.
For young children, encourage parents to offer comfort with holding and cuddling. Older children respond better if they receive praise.
EMLA (lidocaine/prilocaine) cream or a vapocoolant spray, if available, may
be used before the injection to reduce the pain from the needle insertion.
However, because these agents do not absorb down into the muscle, the child
may still experience pain when the medication enters the muscle. Apply EMLA
cream to the site at least 1 hour and up to 3 hours before the injection. Vapocoolant spray is applied to the site immediately before the injection. Another
option is to apply a wrapped ice cube to the injection site for a minute before
the injection. Infants also experience pain with the administration of injections. Breastfeedings during the procedure or administering a glucose solution
have both been effective strategies for pain management.
Air lock
Figs. 10.44 and 10.45 Intradermal injection.
•
•
•
Medication
•
Air lock
Medication
Fig. 10.43 Air-lock technique for intramuscular injections. (From
Elkin, M. K., Perry, A. G., & Potter, P. A. (2012). Nursing interventions
and clinical skills (5th ed.). St. Louis, MO: Mosby.)
Intradermal Injection
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). When giving
an ID injection, keep in mind the following points:
• e sure to choose an appropriate site for the in ection. Avoid
areas of bruising rashes in ammation edema or skin discoloration.
•
•
•
•
•
elp the patient to a comfortable position. Extend and support the elbow and forearm on a at surface.
In general three to four nger widths below the antecubital
space and one hand-width above the wrist are the preferred
locations on the forearm. Areas on the back that are also suitable for subcut injections may be used if the forearm is not
appropriate for the ID injection.
Cleanse the site with an alcohol or antiseptic swab. Apply the
swab at the centre of the site, and cleanse outward in a circular direction for about cm then let the skin dry. A er
cleansing the site, stretch the skin over the site with your
nondominant hand.
ith the needle almost against the patient’s skin insert the
needle, bevel up, at a 5- to 15-degree angle until resistance
is felt, and then advance the needle through the epidermis,
approximately 3 mm (Figures 10.44 and 10.45). The needle
tip should still be visible under the skin.
o not aspirate. This area under the skin contains few blood
vessels.
Slowly in ect the medication. It is normal to feel resistance
and a bleb that resembles a mosquito bite (about 6 mm in
diameter) will form at the site if accurate technique is used.
ithdraw the needle slowly while gently applying a gau e
pad at the site, but do not massage the site.
T RECAP the needle. ispose of the syringe and
needle in the appropriate container. Perform hand hygiene
after administering the medication.
Provide instructions to the patient as needed for a follow up
visit for reading the skin testing, if applicable.
CHAPTER 10 Principles of Drug Administration
147
Fig. 10.48 Giving a subcutaneous injection at a 90-degree angle.
Fig. 10.46 Potential sites for subcutaneous injections. (From Perry,
A. G., & Potter, P. A. (2010). Clinical nursing skills and techniques (7th
ed.). St. Louis, MO: Mosby.)
Fig. 10.49 When giving a subcutaneous injection in the abdomen,
be sure to choose a site at least 5 cm away from the umbilicus.
Fig. 10.47 Before giving an injection, cleanse the skin with an alcohol or antiseptic swab.
•
ocument in the MAR the date of the skin testing and the
date that results need to be read, if applicable.
Subcutaneous Injections
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). When giving
a subcut injection, keep in mind the following points:
• e sure to choose an appropriate site for the in ection. Avoid
areas of bruising rashes in ammation edema or skin discoloration as well as scars, moles, or hair roots (Figure 10.46).
• Ensure that the needle si e is correct. rasp the skin fold
between your thumb and forefinger and measure from top to
bottom. The needle should be approximately one half of this
length.
• Cleanse the site with an alcohol or antiseptic swab. Apply the
swab at the centre of the site, and cleanse outward in a circular direction for about 5 cm (Figure 10.47 then let the skin
dry.
• Tell the patient that he or she will feel a stick as you insert
the needle.
• or a patient who is of average si e pinch the skin with your
nondominant hand, and inject the needle quickly at a 45- or
90-degree angle (Figure 10.48).
• or a patient who is obese pinch the skin and in ect the needle at a 90-degree angle. Be sure the needle is long enough to
reach the base of the skin fold.
• Age related considerations or a child or a thin patient
pinch the skin gently and be sure to use a 45-degree angle
when injecting the needle.
• In ections given in the abdomen must be given at least cm
away from the umbilicus because of the surrounding vascular structure (Figure 10.49). The injection site must also be
5 cm away from any incisions, stomas, or open wounds, if
present.
• A er the needle enters the skin grasp the lower end of the
syringe with your nondominant hand. Move your dominant
hand to the end of the plunger—be careful not to move the
syringe.
• Aspiration of medication to check for blood return is not necessary for subcut in ections or vaccinations Public ealth
Agency of Canada
. eparin sulphate in ections and
insulin injections are NOT aspirated before injection and
need to be injected at a 90-degree angle.
•
ith your dominant hand slowly in ect the medication.
148
•
•
•
•
•
•
•
PART 1 Pharmacology Basics
ithdraw the needle quickly and place a swab or sterile
gauze pad over the site.
Apply gentle pressure but do not massage the site. If necessary, apply a bandage to the site.
T RECAP the needle. ispose of the syringe and
needle in the appropriate container. Perform hand hygiene
after administering the injection.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
or heparin sulphate or other subcut anticoagulant in ections, follow the manufacturer’s instructions for injection
technique as needed. Many manufacturers recommend the
area of the abdomen known as the love handles for in ection of anticoagulants.
T ASPIRATE before in ecting and
T MASSA E the site a er in ection. These
actions may cause a hematoma at the injection site.
eparin doses are ordered in units but it is important to
note that units of heparin sulphate are not the same as units
of insulin. eparin sulphate is never measured with insulin
syringes.
Also available are pre lled syringes with air lock of low molecular-weight heparin (e.g., enoxaparin sodium, dalteparin
sodium). The air lock of 0.2 to 0.3 mL of air is left in the
in ector when the drug is administered followed by the air
a lock is created where the needle is inserted to prevent the
heparin from penetrating the skin. This reduces the possibility of developing a hematoma. In addition, all of the drug is
pushed by the air into the subcutaneous tissue and the precise dose of the drug is administered.
Insulin Syringes
• Always use an insulin syringe to measure and administer
insulin. When giving small doses of insulin, use an insulin syringe that is calibrated for smaller doses. Figure 10.50
shows insulin syringes with two different calibrations. Notice
that in the
unit syringe each line represents units on
the 50-unit syringe, each line represents 1 unit. NOTE: One
unit of insulin is NOT equivalent to one millilitre of insulin.
• Figure 10.51 shows several examples of devices (syringe,
insulin pen) that can be used to help patients self-administer
insulin. These devices feature a multidose container of insulin and easy-to-read dials for choosing the correct dose. The
needle is changed with each use. These devices are for single-patient use only, due to the risk of blood contamination
of the medication reservoir.
•
hen two di erent types of insulin are drawn up into the
same syringe, always draw up the clear (fast-acting) insulin
into the syringe first. An easy way to remember which insulin is drawn up rst is by thinking ast irst.
•
isinfection of the site for insulin is usually not required
however, alcohol or antiseptic swabs are often used in the
hospital or home care setting.
Intramuscular Injections
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves must
Fig. 10.50 Insulin syringes are available in 100-unit and 50-unit calibrations. (From Rick Brady, Riva, MD.)
Fig. 10.51 A variety of devices are available for insulin injections.
(http://www.mdtmag.com/articles/2014/08/advances-diabetes-drug-delivery.)
be worn. When giving an IM injection, keep in mind the following points:
• Choose the appropriate site for the in ection by assessing not
only the size and integrity of the muscle but also the amount and
type of in ection. Palpate potential sites for areas of hardness or
tenderness and note the presence of bruising or infection.
• The dorsogluteal in ection site is no longer recommended for
injections because of its close proximity to the sciatic nerve
and major blood vessels. Injury to the sciatic nerve from an
injection may cause partial paralysis of the leg. The dorsogluteal site is not to be used for IM in ections instead the ventrogluteal site is the preferred IM injection site for adults and
children.
• Assist the patient to the proper position and ensure the
patient’s comfort.
• ocate the proper site for the in ection and cleanse the
site with an alcohol or antiseptic swab. Apply the swab at
the centre of the site, and cleanse outward in a circular
direction for about 5 cm (see Figure 10.47 then let the
skin dry. Keep a sterile gauze pad nearby for use after the
injection.
•
ith your nondominant hand pull the skin taut. ollow the
instructions for the Z-track method (see below), if appropriate.
CHAPTER 10 Principles of Drug Administration
•
•
•
•
•
•
•
rasp the syringe with your dominant hand between thumb
and index finger, as if holding a dart, and hold the needle at a
degree angle to the skin. Tell the patient to expect a stick
feeling as you insert the needle.
Insert the needle quickly and rmly into the muscle. rasp
the lower end of the syringe with the nondominant hand
while still holding the skin back, to stabilize the syringe.
With the dominant hand, pull back on the plunger for 5 to
10 seconds to check for blood return.
If no blood appears in the syringe in ect the medication
slowly, at the rate of 1 mL every 10 seconds. After injecting
the drug, wait 10 seconds, and then withdraw the needle
smoothly while releasing the skin.
Apply gentle pressure at the site and watch for bleeding.
Apply a bandage if necessary.
If blood does appear in the syringe remove the needle
dispose of the medication and syringe, and prepare a new
syringe with the medication.
T RECAP the needle. ispose of the syringe and
needle in the appropriate container. Remove gloves and perform hand hygiene.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Z-Track Method
• The track method is used for in ections of irritating substances such as iron dextran and hydroxyzine hydrochloride.
The technique reduces pain, irritation, and staining at the
in ection site. Some facilities recommend this method for all
IM injections (Figures 10.52 and 10.53).
• A er choosing and preparing the site for in ection use your
nondominant hand to pull the skin laterally, and hold it in
this position while giving the injection. When using this
technique in the older adult population, it may not be necessary to pull the skin as much as in a younger adult because of
loose skin turgor. Insert the needle at a 90-degree angle, aspirate for 5 to 10 seconds to check for blood return, and then
inject the medication slowly. After injecting the medication,
wait 10 seconds before withdrawing the needle. Withdraw
the needle slowly and smoothly, and maintain the 90-degree
angle.
• Release the skin immediately a er withdrawing the needle
to seal off the injection site. This technique forms a Z-shaped
track in the tissue that prevents the medication from leaking through the more sensitive subcutaneous tissue from the
muscle site of injection. Apply gentle pressure to the site with
a dry gauze pad.
Ventrogluteal Site
• The ventrogluteal site is the preferred site for adults and
children. It is considered the safest of all the sites because
the muscle is deep and away from major blood vessels and
nerves (Figure 10.54).
• Position the patient on one side with knees bent and upper
leg slightly ahead of the bottom leg. If necessary, the patient
may remain in a supine position.
149
Medication
Injection track seals
as skin is released
Skin
Subcutaneous
tissue
Muscle
Medication
After release
Figs. 10.52 and 10.53 The Z-track method for intramuscular injections. (From Perry, A. G., & Potter, P. A. (2010). Clinical nursing skills and
techniques (7th ed.). St. Louis, MO: Mosby.)
Iliac crest
Site of
Anterosuperior
injection
iliac spine
Fig. 10.54 Finding landmarks for a ventrogluteal injection. (Modified from Potter, P. A., & Perry, A. G. (1993). Fundamentals of nursing:
Concepts, process, and practice (3rd ed.). St. Louis, MO: Mosby.)
• Palpate the greater trochanter at the head of the femur
and the anterosuperior iliac spine. As illustrated in Figure
10.55, use the left hand to find landmarks when injecting
into the patient’s right ventrogluteal, and the right hand to
find landmarks when injecting into the patient’s left ventrogluteal site. Place the palm of your hand over the greater
trochanter and your index finger on the anterosuperior iliac
150
PART 1 Pharmacology Basics
Fig. 10.57 Vastus lateralis intramuscular injection in an infant.
(From Rick Brady, Riva, MD.)
Greater
trochanter
of femur
Vastus
lateralis
muscle
Site of
injection
Lateral
femoral
condyle
Figs. 10.55 and 10.56 Ventrogluteal intramuscular injection. (From
Rick Brady, Riva, MD.)
spine. Point your thumb toward the patient’s groin and your
ngers toward the patient’s head. Spread the middle nger
back along the iliac crest, toward the buttocks, as much as
possible.
• The in ection site is the centre of the triangle formed by your
middle and index fingers (see arrow in Figure 10.55).
• efore giving the in ection you may need to switch hands so
that you can use your dominant hand to give the injection
(Figure 10.56).
• ollow the general instructions for giving an IM in ection.
Vastus Lateralis Site
•
enerally the vastus lateralis muscle is well developed and
not located near major nerves or blood vessels. It is the preferred site of injection of drugs such as immunizations for
infants (Figure 10.57). For specific information about giving
injections to children, see Box 10.2.
• The patient may be sitting or lying supine if supine have the
patient bend the knee of the leg in which the injection will be
given.
• To nd the correct site of in ection place one hand above
the knee and one hand below the greater trochanter of the
femur. Locate the midline of the anterior thigh and the
midline of the lateral side of the thigh. The injection site is
located within the rectangular area (Figures 10.58, 10.59,
and 10.60).
Figs. 10.58, 10.59, and 10.60 Vastus lateralis intramuscular injection. (For Figure 10.58: modified from Potter, P. A., & Perry, A. G. (1993).
Fundamentals of nursing: Concepts, process, and practice (3rd ed.). St.
Louis, MO: Mosby.) (For Figure 10.59: from Rick Brady, Riva, MD.) (For
Figure 10.60: from Rick Brady, Riva, MD.)
CHAPTER 10 Principles of Drug Administration
Deltoid Site
• Even though the deltoid site Figure 10.61) is easily accessible, it is not the first choice for IM injections because the
muscle may not be well developed in some adults, and the
site carries a potential for injury because the axillary nerve
lies beneath the deltoid muscle. In addition, the brachial
artery and radial, brachial, and ulnar nerves are also located
in the upper arm. Always check medication administration
policies, because some facilities do not use the deltoid site for
IM injections. The deltoid site must be used only for giving
immunizations to toddlers, older children, and adults (not
infants) and only for small volumes of medication (0.5 to 1
mL).
• The patient may be sitting or lying down. Remove clothing to
expose the upper arm and shoulder. Do not roll up tight-fitting sleeves. ave the patient relax the arm and slightly bend
the elbow.
• Palpate the lower edge of the acromion process. This edge
becomes the base of an imaginary triangle (Figure 10.62).
• Place three fingers below this edge of the acromion process. Find the point on the lateral arm in line with the
axilla. The injection site will be in the centre of this triangle, three finger widths (2.5 to 5 cm) below the acromion
process.
• Age related considerations In children and smaller adults
it may be necessary to bunch the underlying tissue together
before giving the injection and use a shorter (16 mm) needle
(Figure 10.63).
• To reduce patient anxiety have the patient look away before
you give the injection.
151
Deltoid muscle
Site of injection
Preparing Intravenous Medications
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn for these procedures. Check the agency policy. When
administering intravenous drugs, keep in mind the following
points:
• The intravenous route for medication administration
provides for rapid onset and faster therapeutic drug levels in the blood than other routes. owever the intravenous route is also potentially more dangerous. Once an
intravenous drug is given, it begins to act immediately
and cannot be removed. The nurse must be aware of the
drug’s intended effects and possible adverse effects. In
addition, hypersensitivity (allergic) reactions may occur
quickly.
• Most Canadian provinces e.g. Alberta Manitoba ntario
Saskatchewan have passed laws or regulations pertaining to
the use of safety-engineered devices (needleless systems for
infusion lines).
• efore giving an intravenous medication assess the patient’s
drug allergies, the intravenous line for patency, and the site
for signs of phlebitis or infiltration.
•
hen more than one intravenous medication is to be given
check with the pharmacy for compatibility if medications are
to be infused at the same time.
• Check the expiration date of both the medication and infusion bags.
Figs. 10.61, 10.62, and 10.63 Deltoid intramuscular injection. (For
Figure 10.61: modified from Potter, P. A., & Perry, A. G. (1993). Fundamentals of nursing: Concepts, process, and practice (3rd ed.). St. Louis,
MO: Mosby.)
• Age related considerations or children infusion pumps
must be used to prevent the risk of infusing the uid and
medication too fast.
• In many institutions the pharmacy prepares the intravenous
solutions and intravenous piggyback I P
admixtures
under a special laminar air ow hood. Most I P medications
152
PART 1 Pharmacology Basics
Fig. 10.64 Two types of intravenous piggyback (IVPB) medication
delivery systems. These IVPB medications must be activated before
administration to the patient. (From Rick Brady, Riva, MD.)
•
•
•
•
•
•
come in vials that are added to the intravenous bag just before
administration. When you dilute a drug for intravenous use,
contact the pharmacist for instructions. Be sure to verify
which type of uid to use and the correct amount of solution
for the dosage according to agency-specific guidelines or protocols for I medication dilution and administration.
Many I P medications are provided as part of an add a
vial system that allows the intravenous medication vial to
be attached to a small-volume minibag for administration.
Figure 10.64 shows two examples of I P medications
attached to small-volume infusion bags.
These IP
medication set ups allow for mixing of the drug
and diluent immediately before the medication is given.
Remember that if the seals are not broken and the medication is not mixed with the uid in the infusion bag then the
medication stays in the vial. As a result, the patient does not
receive the ordered drug dose instead the patient receives a
small amount of plain intravenous uid.
It is important to choose the correct solution for diluting
intravenous medications. For example, phenytoin must be
infused with normal saline S not dextrose solutions see
Chapter 15). Check with the pharmacist if necessary.
ne type of I P that needs to be activated before administration is illustrated in Figure 10.65. To activate this type
of I P system snap the connection area between the
intravenous infusion bag and the vial (Figure 10.66). Gently squee e the uid from the infusion bag into the vial and
allow the medication to dissolve (Figure 10.67). After a few
minutes, rotate the vial gently to ensure that all the powder
is dissolved. hen the drug is fully dissolved hold the I P
apparatus by the vial and squee e the bag uid will enter
the bag from the vial. Make sure that all the medication is
returned to the I P bag.
hen hanging these I P medications take care
T to
squee e the bag. This may cause some of the uid to leak
back into the vial and alter the dose given.
Always label the I P bag with the patient’s name and room
number, the name of the medication, the dose, the date and
time mixed, your initials, and the date and time the medication was given.
Fig. 10.65 Activating an IVPB infusion bag (step 1). (From Rick
Brady, Riva, MD.)
Fig. 10.66 Activating an IVPB infusion bag (step 2). (From Rick
Brady, Riva, MD.)
Fig. 10.67 Activating an IVPB infusion bag (step 3). (From Rick
Brady, Riva, MD.)
CHAPTER 10 Principles of Drug Administration
153
• Some intravenous medications must be mixed using a needle and syringe. In many facilities, this procedure may be
performed in the pharmacy. If you are mixing the I medication be sure to verify which type of uid to use and the
correct amount of solution for the dosage according to agency speci c guidelines or protocols for I medication dilution and administration. After checking the order and the
compatibility of the drug and the intravenous uid wipe the
port of the intravenous bag with an alcohol swab (Figure
10.68).
• Carefully insert the needle into the centre of the port and
inject the medication (Figures 10.69 and 10.70). Note how
the medication remains in the lower part of the intravenous
infusion bag. Turn the bag gently end to end to mix the uid
and added medication (Figure 10.71).
• Always add medication to a new bag of intravenous uid not to
a bag that has partially infused. The concentration of the medication may be too strong if it is added to a partially full bag.
• Always label the intravenous infusion bag when a drug has
been added (Figure 10.72). Label as per institution policy
and include the patient’s name and room number, the name
of the medication, the date and time mixed, your initials, and
the date and time the infusion was started. In addition, label
all intravenous infusion tubing per institution policy.
Infusions of Intravenous Piggyback Medications
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves must
be worn.
• Refrigerated medications may need to be le on the counter
to warm to room temperature before administering. If you
are infusing the I P medication for the rst time you will
need to attach the medication bag to the appropriate tubing
and prime the tubing by allowing ust enough uid through
the tubing to ush out the air. Take care not to waste too
much of the medication when ushing the tubing.
• If you are adding I P medication to an infusion that
already has tubing then use the technique of backpriming to ush the tubing Figure 10.73). Backpriming allows
for the administration of multiple intravenous medications
without multiple disconnections, and thus reduces the risk
of contamination of the intravenous tubing system.
• ackpriming allows the removal of the old medication uid
that has remained in the I P tubing from the previous dose
of intravenous medication. After ensuring that the medication in the primary infusion (if any) is compatible with the
medication in the I P bag close the roller clamp on the
primary infusion if the intravenous uid is infusing by gravity ow not necessary if an infusion pump is used . Remove
the empty I P container from the intravenous pole lower
it to below the level of the primary infusion bag, and open the
clamp on the I P tubing. This will allow uid to ow from
the primary intravenous bag into the empty I P bag. Then
close the clamp on the I P tubing and squee e the uid
that is in the drip chamber into the old I P bag to remove
the old medication uid. At this point you may attach the
new dose of intravenous medication to the I P tubing.
Figs. 10.68, 10.69, and 10.70 Adding a medication to a full intravenous infusion bag with a needle and syringe (prior to initiating the
infusion). (From Rick Brady, Riva, MD.)
154
PART 1 Pharmacology Basics
Fig. 10.71 Mix the medication thoroughly before infusing. (From
Rick Brady, Riva, MD.)
Fig. 10.72 Label the intravenous infusion bag when medication has
been added. (From Rick Brady, Riva, MD.)
•
ackpriming will not be possible if the primary intravenous
infusion contains heparin sulphate, aminophylline, a vasopressor, or multivitamins. Check with a pharmacist if unsure
about compatibility.
• Stopping intravenous infusions of medications such as
vasopressors for an I P medication may a ect a patient’s
blood pressure stopping intravenous heparin may a ect the
patient’s coagulation levels. Be sure to assess carefully before
adding an I P medication to an existing infusion. A separate intravenous line may be necessary.
• Figure 10.74 shows an I P medication infusion also
known as the secondary infusion) with a primary gravity
Fig. 10.73 Flush the intravenous piggyback (secondary) tubing by
using the backpriming method. Fluid is drained through the tubing
into the old intravenous piggyback bag, which is then discarded.
The new dose of medication is then attached to the primed secondary tubing.
Fig. 10.74 Infusing an IVPB medication with a primary gravity intravenous infusion. (From Rick Brady, Riva, MD.)
infusion. hen the I P bag is hung higher than the primary intravenous infusion bag the I P medication will
infuse until empty, and then the primary infusion will take
over again.
•
hen beginning the infusion attach the I P tubing to the
upper port on the primary intravenous tubing. A back-check
valve above this port prevents the medication from infusing
up into the primary intravenous infusion bag.
• ully open the clamp of the I P tubing and regulate the
infusion rate with the roller clamp of the primary infusion
tubing. Be sure to note the drip factor of the tubing and calculate the drops per minute count to set the correct infusion
rate for the I P .
CHAPTER 10 Principles of Drug Administration
155
Fig. 10.76 Instructing the patient on the use of a patient-controlled
analgesia (PCA) pump. (From Perry, A. G., & Potter, P. A. (2010). Clinical nursing skills and techniques (7th ed.). St. Louis, MO: Mosby.)
Fig. 10.75 Infusing an IVPB medication with the primary intravenous infusion on an electronic infusion pump. (From Rick Brady,
Riva, MD.)
• Monitor the patient during the infusion. bserve for hypersensitivity and for adverse reactions. In addition, observe the
intravenous infusion site for in ltration. ave the patient
report if pain or burning occurs.
• Monitor the rate of infusion during the I P administration. Changes in arm position may alter the infusion rate.
•
hen the infusion is complete clamp the I P tubing and
check the primary intravenous infusion rate. If necessary,
adjust the clamp to the correct infusion rate.
• Figure 10.75 shows an I P medication infusion with a primary infusion that is running through an electronic infusion
pump.
•
hen giving I P drugs through an intravenous infusion
controlled by a pump attach the I P tubing to the port on
the primary intravenous tubing above the pump. Open the
roller clamp of the I P medication tubing. Make sure that
the I P bag is higher than the primary intravenous infusion bag.
• ollowing the manufacturer’s instructions set the infusion
pump to deliver the I P medication. Entering the volume
of the I P bag and the desired time frame of the infusion
(e.g., over a 60-minute period) will cause the pump to automatically calculate the I P rate. Start the I P infusion as
instructed by the pump.
• Monitor the patient during the infusion as described earlier.
•
hen the infusion is complete the primary intravenous
infusion will automatically resume.
•
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
•
hen giving intravenous medications through a saline heparin lock follow the facility’s guidelines for the ushing protocol before and after the medication is administered.
Fig. 10.77 An electronic smart pump. The two components on the
right side are a patient-controlled analgesia pump. (From Perry, A.
G., & Potter, P. A. (2014). Clinical nursing skills and techniques (8th ed.).
St. Louis, MO: Mosby.)
• In patient controlled analgesia PCA a speciali ed pump
is used to allow patients to self-administer pain medications, usually opiates (Figure 10.76). These pumps allow
the patient to self-administer only as much medication as
needed to control the pain, by pushing a button for intravenous bolus doses. Safety features of the pump prevent
accidental overdoses. A patient receiving PCA pump infusions should be monitored closely for response to the drug,
excessive sedation, hypotension, and changes in mental and
respiratory status. Follow the facility’s guidelines for set-up
and use.
• Figure 10.77 displays a smart pump, a type of intravenous
infusion safety system designed to reduce intravenous medication errors. A smart pump contains built-in software that
is programmed with facility-specific dosing profiles. The
pump is able to check the dose limits and other clinical
guidelines, and when the pump is set up for patient use, it
can warn the nurse if a potentially unsafe drug dose or therapy is entered.
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PART 1 Pharmacology Basics
Intravenous Push Medications
Always begin by performing hand hygiene and maintain
standard precautions/routine practices (see Box 10.1). When
administering intravenous push (or bolus) medications, keep in
mind the following points:
• Registered nurses are usually the only nursing sta members
allowed to give intravenous push medications. This may vary
at different facilities.
• Intravenous push in ections allow for rapid intravenous
administration of a drug. The term bolus refers to a dose
given all at once. Intravenous push injections may be given
through an existing intravenous line, through an intravenous
(saline or heparin) lock, or directly into a vein.
• ecause the medication may have an immediate e ect monitor the patient closely for therapeutic effects as well as for
adverse reactions.
• ollow the pharmacy or manufacturer’s instructions carefully when preparing an intravenous push medication. Some
drugs require careful dilution. Consult the pharmacist if
unsure about the dilution procedure. Improper dilution
may increase the risk of phlebitis and other complications.
Always follow the agency guidelines or policies for dilution
and administration of I push medications.
• Some drugs are never given by intravenous push. Examples
include dopamine, potassium chloride, and antibiotics such as
vancomycin. Some medications administered by I push require
specific monitoring and are given only in specialty areas such as
the emergency department and Critical Care Unit. ollow agency
protocols on the administration of drugs given by I push.
• Small amounts of medication—less than m —need to be
diluted in to
m of S or another compatible uid to
ensure that the medication does not collect in a dead space of
the tubing (such as the Y-site port). Check the facility’s policy.
• Most drugs given by intravenous push in ection are to be given
over a period of 1 to 5 minutes to reduce local or systemic
adverse effects. Always time the administration with your watch
because it is di cult to estimate the time accurately. Adenosine, however, must be given rapidly, within 2 to 3 seconds, for
optimal action. A A S check packaging information for
guidelines, because many errors and adverse effects have been
associated with too-rapid intravenous drug administration.
Intravenous Push Medications Through a Peripheral
Intravenous Lock
•
btain two syringes of .
S both syringes should
contain the required amount of fluid or solution according to agency policy. (Facilities may differ in protocol for
intravenous lock flushes.) Many facilities provide prefilled
syringes. Prepare medication for in ection. If ordered
prepare a syringe with heparin sulphate flush solution.
• ollow the guidelines for a needleless system if used.
• Cleanse the in ection port of the intravenous lock with an
alcohol or antiseptic swab for 15 seconds or according to
agency protocol (Figure 10.78).
• Insert the syringe of S into the in ection port Figure 10.79
a needleless system is shown). Open the clamp of the intravenous lock tubing, if present.
Fig. 10.78 Cleanse the port before attaching the syringe. (From Rick
Brady, Riva, MD.)
Fig. 10.79 Attaching the syringe to the intravenous lock. (From Rick
Brady, Riva, MD.)
•
•
•
•
•
•
•
ently aspirate and observe for blood return. e sure to
follow the agency policy regarding the need to aspirate for
blood. Absence of blood return does not mean that the intravenous line is occluded further assessment may be required.
lush gently with saline while assessing for resistance. A
push pause technique is recommended when instilling ush
solution e.g. give m to m of ush pause give another
ml of ush pause give another m to m of ush and
repeat until completed). The push-pause action creates turbulence within the needleless connector and catheter for
more thorough ushing. If you feel resistance do not apply
force. Stop and reassess the intravenous lock.
bserve for signs of in ltration while in ecting saline.
Reclamp the tubing if a clamp is present and remove the S
syringe. Repeat cleansing of the port and attach the medication syringe. Open the clamp again.
In ect the medication over the prescribed length of time.
Measure time with a watch or clock (Figure 10.80).
hen the medication is infused clamp the intravenous lock
tubing (if a clamp is present), and remove the syringe.
Repeat cleansing of the port attach a
m S syringe and
inject the contents into the intravenous lock slowly. If a heparin sodium ush is ordered attach the syringe containing
CHAPTER 10 Principles of Drug Administration
Fig. 10.80 Slowly inject the intravenous push medication through
the intravenous lock; use a watch to time the injection. (From Rick
Brady, Riva, MD.)
157
Fig. 10.81 When giving an intravenous push medication through
an intravenous line, pinch the tubing just above the injection port.
(From Rick Brady, Riva, MD.)
the heparin sodium ush solution and in ect slowly per the
institution’s protocol).
Intravenous Push Medications Through an Existing
Infusion
• Prepare the medication for in ection. ollow the guidelines
for a needleless system, if used.
• Check compatibility of the intravenous medication with the
existing intravenous solution.
• Choose the in ection port that is closest to the patient.
• Remove the cap if present and cleanse the in ection port
with an alcohol or antiseptic swab.
•
cclude the intravenous line by pinching the tubing ust
above the injection port (Figure 10.81). Attach the syringe to
the injection port.
•
ently aspirate for blood return.
•
hile keeping the intravenous tubing clamped slowly in ect
the medication according to administration guidelines. Be
sure to time the injection with a watch or clock.
• A er the in ection release the intravenous tubing remove the
syringe and check the infusion rate of the intravenous uid.
After Injecting an Intravenous Push Medication
• Monitor the patient closely for adverse e ects. Monitor the
intravenous infusion site for signs of phlebitis and infiltration.
•
ocument medication given on the MAR see Figure 10.5),
and monitor the patient for therapeutic response as well as
adverse effects.
TOPICAL DRUGS
Administering Eye Medications
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn. When administering eye preparations, keep in mind
the following points:
• Assist the patient to a supine or sitting position. The patient’s
head should be tilted back slightly. Make sure the patient is
not wearing contact lenses.
Fig. 10.82 Cleanse the eye, washing from the inner canthus to the
outer canthus, before giving eye medications. (From Perry, A. G., &
Potter, P. A. (2006). Clinical nursing skills and techniques (6th ed.). St.
Louis, MO: Mosby.)
• Remove any secretions with a sterile gau e pad be sure to
wipe from the inner to the outer canthus (Figure 10.82).
• Instruct the patient to tilt the head slightly back. ith your
nondominant hand, gently pull the lower lid open to expose
the conjunctival sac.
Eye Drops
•
ith your dominant hand resting on the patient’s forehead
hold the eye medication dropper 1 to 2 cm above the conjunctival sac. Do not touch the tip of the dropper to the eye
or with your fingers (Figure 10.83).
•
rop the prescribed number of drops into the con unctival
sac. Never apply eye drops to the cornea.
• If the drops land on the outer lid margins if the patient
moved or blinked), repeat the procedure.
• Age related considerations Infants o en squee e the eyes
tightly shut to avoid eye drops. To give drops to an uncooperative infant, restrain the head gently and place the drops
at the corner where the eyelids meet the nose. When the eye
opens the medication will ow into the eye.
158
PART 1 Pharmacology Basics
Fig. 10.83 Insert the eye drop into the lower conjunctival sac. (From
Elkin, M. K., Perry, A. G., & Potter, P. A. (2004). Nursing interventions
and clinical skills (3rd ed.). St. Louis, MO: Mosby.)
Fig. 10.84 Applying eye ointment. (From Rick Brady, Riva, MD.)
Eye Ointment
Gently squeeze the tube of medication to apply an even strip of
medication (about 1 to 2 cm) along the border of the conjunctival sac. Start at the inner canthus and move toward the outer
canthus (Figure 10.84).
After Instilling Eye Medications
• Ask the patient to close the eye gently. Squee ing the eye shut
may force the medication out of the conjunctival sac. A tissue may be used to blot liquid that runs out of the eye, but
instruct the patient not to wipe the eye.
• ou may apply gentle pressure to the patient’s nasolacrimal
duct for 30 to 60 seconds, with a gloved finger wrapped in a
tissue. This will help reduce systemic absorption of the drug
through the nasolacrimal duct and may also help to reduce
the taste of the medication in the oropharynx from the nasopharynx (Figure 10.85).
• If multiple eye drops are due at the same time wait several
minutes before administering the second medication. Check
the instructions for the specific drug.
• Assist the patient to a comfortable position. arn the patient
that vision may be blurry for a few minutes.
•
ocument the medication given on the MAR see Figure
10.5), and check the patient for a therapeutic response as well
as for adverse reactions.
Fig. 10.85 Applying gentle pressure against the nasolacrimal duct
after giving eye medications. (From Rick Brady, Riva, MD.)
Fig. 10.86 With adults, pull the pinna up and back. (From Rick Brady,
Riva, MD.)
Administering Eardrops
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn. When administering ear medications, keep in mind
the following points:
• A er explaining the procedure to the patient assist the
patient to a side-lying position with the affected ear facing
up. If drainage is noted in the outer ear canal, remove it carefully without pushing it back into the ear canal.
• Remove excessive amounts of cerumen before instilling
medication.
• If refrigerated warm the ear medication by taking it out of
refrigeration for at least 30 minutes before administration.
Instillation of cold eardrops can cause nausea, dizziness, and
pain.
• Age related considerations or an adult or a child years
or older, pull the pinna up and back (Figure 10.86). For an
infant or a child younger than 3 years of age, pull the pinna
down and back (Figure 10.87).
• Administer the prescribed number of drops. irect the drops
along the sides of the ear canal rather than directly onto the
eardrum.
CHAPTER 10 Principles of Drug Administration
Fig. 10.87 With infants and children under 3 years of age, pull the
pinna down and back. (From Rick Brady, Riva, MD.)
• Instruct the patient to lie on one side for to
minutes.
Gently massaging the tragus of the ear with a finger will help
distribute the medication down the ear canal.
• If ordered a loose cotton pledget can be gently inserted
into the ear canal to prevent the medication from flowing out. The cotton must remain somewhat loose to allow
any discharge to drain out of the ear canal. To prevent
the dry cotton from absorbing the eardrops that were
instilled, moisten the cotton with a small amount of medication before inserting the pledget. Insertion of cotton
too deeply may result in increased pressure within the ear
canal and on the eardrum. Remove the cotton after about
15 minutes.
• If medication is needed in the other ear wait to minutes
after instillation of the first eardrops before administering.
•
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
Administering Nasal Medications
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1 . Patients may
self-administer some of these drugs after proper instruction.
Gloves must be worn. When administering nasal medications,
keep in mind the following points:
• efore giving nasal medications explain the procedure to
the patient and tell the patient that temporary burning or
stinging may occur. Instruct the patient that it is important to clear the nasal passages by blowing the nose, unless
contraindicated (e.g., with increased intracranial pressure or
nasal surgery), before administering the medication. Assess
for deviated septum or a history of nasal fractures, because
these may impede the patient’s ability to inhale through the
affected nostril.
• Figure 10.88 illustrates delivery forms for nasal medications:
sprays, drops, and dose-measured sprays.
• Assist the patient to the supine position. Support the patient’s
head as needed.
A
159
B
Fig. 10.88 Nasal medications in various delivery forms. (Flonase®
photo reproduced with permission from GlaxoSmithKline Inc., Canada.
All rights reserved. Nasonex® photo reproduced with permission from
Schering Canada, Inc. All rights reserved.)
Fig. 10.89 Administering nose drops.
• If speci c areas are targeted for the medication position the
patient’s head as follows:
• or the posterior pharynx position the head backward.
• or the ethmoid or sphenoid sinuses place the head gently over the top edge of the bed or place a pillow under the
shoulders, and tilt the head back.
• or the frontal or maxillary sinuses place the head back
and turned toward the side that is to receive the medication.
Nasal Drops
•
old the nose dropper approximately cm above the nostril.
Administer the prescribed number of drops toward the midline of the ethmoid bone (Figure 10.89).
• Repeat the procedure as ordered instilling the indicated
number of drops per nostril.
• Keep the patient in the supine position for minutes.
• Age related considerations Infants are nose breathers and
the potential congestion caused by nasal medications may
make it di cult for them to suck. If nose drops are ordered
administer them 20 to 30 minutes before a feeding.
160
PART 1 Pharmacology Basics
Fig. 10.90 Before self-administering the nasal spray, the patient
should occlude the other nostril and spray the medication away
from the septum.
Fig. 10.91 A, Metered-dose inhaler (MDI). B, Automated MDI. C,
“Disk-type” MDI for delivering powdered medication. (From Rick
Brady, Riva, MD.)
Nasal Spray
•
ave the patient sit upright and occlude one nostril by pressing a finger against the outer naris. After gently shaking the
nasal spray container insert the tip into the nostril. Squee e
the spray bottle into the nostril while the patient inhales
through the open nostril (Figure 10.90).
• Repeat the procedure as ordered instilling the indicated
number of sprays per nostril.
• Keep the patient in the supine position for minutes.
After Administration of Nasal Medicines
•
er the patient tissues for blotting any drainage but instruct
the patient to avoid blowing her nose for several minutes
after instillation of the drops or spray.
• Assist the patient to a comfortable position.
•
ocument the medication administration on the MAR see
Figure 10.5), and document drainage, if any. Monitor the
patient for a therapeutic response as well as for adverse reactions.
Administering Inhaled Drugs
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves may
be worn. Patients with asthma need to monitor their peak expiratory ow rates by using a peak owmeter. A variety of inhalers are available (Figure 10.91). Be sure to check for specific
instructions from the manufacturer, as needed. Improper use
will result in inadequate dosing and lack of therapeutic effect.
When administering inhaled preparations, keep in mind the
following points:
Metered-Dose Inhalers
• A spacer is always used with a pressured metered dose
inhaler M I that delivers inhaled corticosteroids. Spacers
can make it easier for medication to reach the lungs, and also
mean that less medication gets deposited in the mouth and
throat, where it can lead to irritation and mild infections.
Fig. 10.92 Using an MDI without a spacer. (From Elkin, M. K., Perry,
A. G., & Potter, P. A. (2004). Nursing interventions and clinical skills (3rd
ed.). St. Louis, MO: Mosby.)
• Shake the M I gently before using.
• Remove the cap hold the inhaler upright and grasp with the
thumb and first two fingers.
• Tilt the patient’s head back slightly.
• If the M I is used without a spacer do the following Remove
the inhaler cap hold the inhaler upright and grasp with the
thumb and first two fingers.
. ave the patient open his mouth position the inhaler
to 5 cm away from the mouth (Figure 10.92). For self-administration, some patients may measure this distance as
1 to 2 finger-widths.
. ave the patient exhale then press down once on the
inhaler to release the medication have the patient breathe
in slowly and deeply for 5 seconds.
. ave the patient hold his breath for approximately seconds and then exhale slowly through pursed lips.
• Age related consideration Spacers can be used with children
and adults who have di culty coordinating inhalations with
CHAPTER 10 Principles of Drug Administration
161
Fig. 10.93 Using a spacer device with an MDI. (From Rick Brady,
Riva, MD.)
•
•
•
•
•
•
activation of metered-dose inhalers (see Chapter 38). If the
inhaler is used with a spacer, do the following:
1. Remove the inhaler cap and then attach the spacer to the
mouthpiece of the inhaler.
. Place the mouthpiece of the spacer in the patient’s mouth.
. ave the patient exhale.
. Press down on the inhaler to release the medication and
have the patient inhale deeply and slowly through the
spacer. The patient then breathes in and out slowly for
2 to 3 seconds and then holds her breath for 10 seconds
(Figure 10.93).
5. Clean the spacer. Take the spacer apart and gently move
the parts back and forth in warm, soapy water. Avoid the
use of high-pressure or boiling hot water, rubbing alcohol,
or disinfectant. Rinse the parts well in clean water. Do not
dry the inside of the spacer with a towel as it will create
static rather air dry.
If a second pu of the same medication is ordered wait to
2 minutes between puffs.
If a second type of inhaled medication is ordered wait to
minutes between medication inhalations or as prescribed.
If both a bronchodilator and a corticosteroid inhaled medication are ordered, the bronchodilator should be administered first so that the air passages will be more open for the
second medication.
Instruct the patient to rinse the mouth with water a er inhaling a steroid medication to prevent the development of an
oral fungal infection.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
It is important to teach the patient how to calculate the number of doses in the inhaler and to keep track of uses. Simply
shaking the inhaler to estimate whether it is empty is not
accurate and may result in its being used when it is empty.
Many metered-dose inhalers now come with devices that
help to count the remaining doses. If the inhaler does not
have a dose-counting device, the patient should be taught to
count the number of puffs needed per day (doses) and divide
this amount into the actual number of actuations (puffs) in
Fig. 10.94 Adding medication to the nebulizer cup.
the inhaler to estimate the number of days the inhaler will
last. Then, a calendar can be marked a few days before this
date with a note that it is time to obtain a refill. In addition,
the date can be marked on the inhaler with a permanent
marker. For example, an inhaler with 200 puffs, ordered to be
used 4 times a day (2 puffs per dose, 8 puffs per day), would
last for 25 days (200 divided by 8). The patient may experience the sensation of a puff even when the canister is empty.
This sensation occurs from the propellant even if there is little or no drug in the puff, and it is, therefore, not effective.
Dry powder inhalers have varied instructions, so follow the
manufacturer’s instructions closely. Instruct patients to cover
the mouthpiece completely with their mouths. Capsules that
are intended for use with these inhalers should E ER be
taken orally. Some dry powder inhalers also have convenient
built-in dose counters.
Small-Volume Nebulizers
• Check the doctor’s order regarding the use of compressed air
or oxygen for the administration of the nebulizer treatment.
• In some facilities the air compressor is located in the wall
unit of the room. In other facilities and at home, a small, portable air compressor is used. Be sure to follow the manufacturer’s instructions for use.
• In some facilities nebuli er treatments may be performed by
a respiratory therapist. owever closely monitor the patient
before, during, and after the drug administration.
• e sure to take the patient’s baseline heart rate especially if a
beta adrenergic drug is used. Some drugs may increase the
heart rate.
• A er gathering the equipment add the prescribed medication to the nebulizer cup (Figure 10.94 . Some medications
will require a diluent others are premixed with a diluent. e
sure to verify before adding a diluent.
162
PART 1 Pharmacology Basics
Fig. 10.95 Administering a small-volume nebulizer treatment.
(From Rick Brady, Riva, MD.)
•
•
•
•
•
•
•
•
•
•
•
ave the patient hold the mouthpiece between the lips
(Figure 10.95).
Age related considerations Use a face mask for a child or
an adult who is too fatigued to hold the mouthpiece. Special
adaptors are available if the patient has a tracheostomy.
efore starting the nebuli er treatment have the patient
take a slow deep breath hold it brie y then exhale slowly.
Patients who are short of breath should be instructed to hold
their breath every fourth or fifth breath.
Turn on the small volume nebuli er machine or turn on the
wall unit and make sure that a su cient mist is forming.
Instruct the patient to repeat the breathing pattern mentioned previously during the treatment.
ccasionally tap the nebuli er cup during the treatment and
toward the end to move the uid droplets back to the bottom of the cup.
Monitor the patient’s heart rate during and a er the treatment.
If inhaled steroids are given instruct the patient to rinse his
mouth afterward.
A er the procedure clean and store the tubing per institution policy.
ocument the medication given on the MAR see Figure
10.5), and monitor the patient for a therapeutic response as
well as for adverse reactions.
If the patient will be using a nebuli er at home instruct the
patient to rinse the nebulizer parts daily after each use with
warm clear water and allow to air dry. Soak the nebuli er
parts in a vinegar and water solution (four parts water and
one part white vinegar for
minutes rinse thoroughly
with clear warm water and air dry. Storing nebuli er parts
that are still wet will encourage bacterial and mould growth.
Administering Medications to the Skin
Always begin by performing hand hygiene and maintain standard precautions/routine practices (see Box 10.1). Gloves must
be worn. Avoid touching the preparations to your own skin.
When administering skin preparations, keep in mind the following points:
Fig. 10.96 Use gloves to apply topical skin preparations. (From Rick
Brady, Riva, MD.)
Lotions, Creams, Ointments, and Powders
• Apply powder to clean dry skin. ave the patient turn her
head to the other side during application to avoid inhalation
of powder particles.
• Apply lotion to clean dry skin. Remove residual from previous applications with soap and water.
• efore administering any dose of a topical skin medication
ensure that the site is clean and dry. Thoroughly remove previous applications using soap and water, if appropriate for
the patient’s condition, and dry the area thoroughly. Be sure
to remove any debris, drainage, or pus, if present.
• Age related considerations The skin of an older patient may
be more fragile and easily bruised or damaged (e.g., skin tears
and possible breakdown of skin from use of tape). Be sure to
assess for appropriateness of the skin area before applying
medication, and handle the skin gently when cleansing to
prepare the site for medication and when applying medications.
•
ith lotion cream or gel obtain the correct amount with
your gloved hand (Figure 10.96). If the medication is in a jar,
remove the dose with a sterile tongue depressor and apply to
your gloved hand. Do not contaminate the medication in the
jar.
• Some ointments and creams may soil the patient’s clothes
and linens. If these preparations are ordered, cover the
affected site with gauze or a transparent dressing.
• Although nitroglycerin ointment is not used as frequently
as nitroglycerin transdermal patches, it is still available for
use. Nitroglycerin ointment in a tube is measured carefully
on clean, ruled application paper before it is applied to the
skin. Do not massage nitroglycerin ointment into the skin.
Apply the measured amount onto a clean, dry site and then
secure the application paper with a transparent dressing or a
strip of tape (Figure 10.97). Always remove the old medication before applying a new dose. Rotate application sites.
Transdermal Patches
• e sure that the used patch is removed as ordered. Some
patches may be removed before the next patch is due—check
the order. Clear patches may be di cult to nd and patches
CHAPTER 10 Principles of Drug Administration
163
Fig. 10.98 Opening a transdermal patch medication. (From Rick
Brady, Riva, MD.)
Fig. 10.97 Spread the lotion on the skin with long, smooth, gentle
strokes. (From Rick Brady, Riva, MD.)
•
•
•
•
•
•
•
may be overlooked in obese patients with skin folds. Cleanse
the site of the used patch thoroughly. Observe for signs of
skin irritation at the old patch site. Rotate sites of application
with each dose.
Transdermal patches that are ordered daily should be applied
at the same time each day.
The used patch can be pressed together and then wrapped in
a glove as you remove the glove from your hand. Dispose in
the proper container according to the facility’s policy. Fentanyl patches are to be disposed of in the sharps container.
Select a new site for application and ensure that it is clean
and without powder or lotion. For best absorption and fewest adverse effects, the site needs to be hairless and free from
scratches or irritation. If it is necessary to remove hair, clip
the hair instead of shaving to reduce irritation to the skin.
Application sites may vary. Follow the drug manufacturer’s
specific instructions as to where to apply the patch.
Remove the backing from the new patch Figure 10.98). Take
care not to touch the medication side of the patch with your
fingers.
Place the patch on the skin site and press rmly Figure
10.99 . Press around the edges of the patch with one or two
fingers to ensure that the patch is adequately secured to the
skin. If an overlay is provided by the drug manufacturer,
apply it over the patch.
Instruct the patient not to cut transdermal patches. Cutting
transdermal patches releases all of the medication at once
and may result in a dangerous overdose.
Instruct the patient to safely dispose of the old patch by folding the medicated side facing inward. Using this disposal
method prevents contact with the drug-eluting portion of
the patch.
Fig. 10.99 Ensure that the edges of the transdermal patch are
secure after applying. (From Rick Brady, Riva, MD.)
After Administering Topical Skin Preparations
• Chart the medication given on the MAR see Figure 10.5),
and monitor the patient for a therapeutic response as well as
for adverse reactions.
• Provide instruction on administration to the patient or caregiver.
REFERENCES
Centers for isease Control and Prevention.
. Vaccine administration. Retrieved from http://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html.
Crawford, C. L., & Johnson, J. A. (2012). To aspirate or not: An integrative review of the evidence. Nursing, 42(3), 20–25. https://doi.
org .
. URSE.
.
. .
orld ealth rgani ation.
. WHO guidelines on hand hygiene
in health care: A summary. First global patient safety challenge—
Clean care is safer care. Retrieved from http://www.who.int/gpsc/
5may/tools/who_guidelines-handhygiene_summary.pdf.
orld ealth rgani ation.
. WHO best practices for injections
and related procedures toolkit. eneva C Source. Retrieved from
http://whqlibdoc.who.int/publications/2010/9789241599252_eng.
pdf.
PART 2 Drugs Affecting the Central Nervous System
11
Analgesic Drugs
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Define acute pain and persistent (chronic or long-term)
pain.
2. Contrast the signs, symptoms, and management of acute
and persistent pain.
3. Discuss the pathophysiology and characteristics associated
with cancer pain and other special pain situations.
4. Describe pharmacological and nonpharmacological
approaches for the management and treatment of acute
and persistent pain.
5. Discuss the use of nonopioids, nonsteroidal antiinflammatory drugs (NSAIDs), and opioids (opioid
agonists, opioids with mixed actions, opioid agonist–
antagonists, and antagonists), and miscellaneous drugs in
the management of acute and persistent pain, cancer pain,
and special pain situations.
6. Identify examples of drugs classified as nonopioids,
nonsteroidal anti-inflammatory drugs, opioids (opioid
agonists, opioids with mixed actions, opioid agonist–
antagonists, and antagonists), and miscellaneous drugs.
7. Briefly describe the mechanisms of action, indications,
dosages, routes of administration, adverse effects, toxicity,
cautions, contraindications, and drug interactions of
nonopioids, nonsteroidal anti-inflammatory drugs (see
Chapter 49), opioids (opioid agonists, opioids with mixed
actions, opioid agonist–antagonists, and antagonists), and
miscellaneous drugs.
8. Contrast the pharmacological and nonpharmacological
management of acute and persistent pain associated with
cancer and pain experienced in terminal conditions.
9. Briefly describe the specific standards of pain management
as defined by the World Health Organization and the
Canadian Pain Society.
10. Develop a collaborative plan of care based on the nursing
process as a result of the use of nonopioid and opioid drug
therapy and the nursing process for patients in pain.
11. Identify various resources, agencies, and professional
groups that are involved in establishing standards for the
management of all types of pain and for promotion of
a holistic approach to the care of patients with acute or
persistent pain and those in special pain situations.
KEY TERMS
Acute pain Pain that is sudden in onset, usually subsides
when treated, and typically occurs over less than a 6-week
period. (p. 167)
Addiction Strong psychological or physical dependence on
a drug or other psychoactive substance, usually resulting
from habitual use, that is beyond normal voluntary control.
(p. 171)
Adjuvant analgesic drugs Drugs that are added for combined
therapy with a primary drug and may have additive or
independent analgesic properties, or both. (p. 166)
Agonists Substances that bind to a receptor and cause a
response. (p. 172)
Agonist–antagonists Substances that bind to a receptor and
cause a partial response that is not as strong as that caused
by agonists (also known as partial agonists). (p. 172)
164
Analgesic ceiling effect The effect that occurs when a
particular pain drug no longer effectively controls a patient’s
pain despite the administration of the highest safe dosages.
(p. 172)
Analgesics Medications that relieve pain (sometimes referred
to as painkillers). (p. 166)
Antagonists Substances that bind to a receptor and prevent
(block) a response, resulting in inhibitory or antagonistic
drug effects; also called inhibitors. (p. 173)
Breakthrough pain Pain that occurs between doses of pain
medication. (p. 171)
Cancer pain Pain resulting from any of a variety of causes
resulting from cancer or the metastasis of cancer. (p. 168)
Central pain Pain resulting from any disorder that causes
central nervous system damage. (p. 169)
CHAPTER 11 Analgesic Drugs
Gate control theory A common and well-described theory
of pain transmission and pain relief. It uses a gate model to
explain how impulses from damaged tissues are sensed in
the brain. (p. 169)
Neuropathic pain Pain that results from a disturbance of
function or pathological change in a nerve. (p. 168)
Nociception Processing of pain signals in the brain that gives
rise to the feeling of pain. (p. 166)
Nociceptive pain Pain that arises from mechanical, chemical,
or thermal irritation of peripheral sensory nerves (e.g.,
after surgery or trauma or associated with degenerative
processes). Two subtypes of nociceptive pain are visceral
and somatic. (p. 166)
Nociceptors A subclass of sensory nerves (A and C fibres)
that transmit pain signals to the central nervous system
from other body parts. (p. 166)
Nonopioid analgesics Analgesics that are structurally and
functionally different from opioids. (p. 182)
Nonsteroidal anti-inflammatory drugs (NSAIDs) A large,
chemically diverse group of drugs that are analgesics and
possess anti-inflammatory and antipyretic properties but
are not corticosteroids. (p. 169)
Opiate analgesics Synthetic drugs that bind to opiate
receptors to relieve pain. (p. 173)
Opioid naive A description of patients who are receiving
opioid analgesics for the first time or intermittently for a
brief period of time and who therefore are not accustomed
to their effects. (p. 176)
Opioid tolerant The opposite of opioid naive; a description of
patients who have been receiving opioid analgesics (legally
or otherwise) for a period of time (1 week or longer) and
who are at greater risk of opioid withdrawal syndrome upon
sudden discontinuation. (p. 171)
Opioid withdrawal The signs and symptoms associated with
abstinence from, withdrawal of, or dose reduction of an
DRUG PROFILES
acetaminophen, p. 183
codeine (codeine sulphate)*, p. 178
fentanyl (fentanyl citrate), p. 178
lidocaine, transdermal, p. 184
meperidine (meperidine hydrochloride)*, p. 179
methadone (methadone hydrochloride)*, p. 179
morphine (morphine sulphate)*, p. 178
naloxone (naloxone hydrochloride)*, p. 180
naltrexone (naltrexone hydrochloride)*, p. 180
oxycodone (oxycodone hydrochloride)*, p. 180
tramadol (tramadol hydrochloride)*, p. 183
Key drug
* Full generic name is given in parentheses. For the purposes of this
text, the more common, shortened name is used.
165
opioid analgesic when the body has become physically
dependent on the substance. (p. 176)
Pain An unpleasant sensory and emotional experience
associated with actual or potential tissue damage. (p. 166)
Pain threshold The level of stimulus that results in the
sensation of pain. (p. 167)
Pain tolerance The amount of pain a patient can endure
without its interfering with normal function. (p. 167)
Partial agonist A drug that binds to a receptor and causes a
response that is less than that caused by a full agonist (also
known as agonist–antagonist). (p. 173)
Persistent pain Recurring pain that is often difficult to treat.
Includes any pain lasting longer than 3 to 6 months, pain
lasting longer than 1 month after healing of an acute injury,
or pain that accompanies a nonhealing tissue injury. (Also
referred to as chronic or long-term pain). (p. 167)
Phantom pain Pain experienced in an area of the body part
that has been surgically or traumatically removed. (p. 168)
Psychological dependence A pattern of compulsive use of
opioids or any other addictive substance characterized by a
continuous craving for the substance and the need to use it
for effects other than pain relief (also called addiction).
(p. 171)
Referred pain Pain occurring in an area away from the organ
of origin. (p. 168)
Synergistic effects Drug interactions in which the effect of a
combination of two or more drugs with similar actions is
greater than the sum of the individual effects of the same
drugs given alone. (p. 171)
Tolerance A progressively decreased responsiveness to a drug,
resulting in a need for a larger dose of the drug to achieve
the effect originally obtained by a smaller dose. (p. 167)
Vascular pain Pain that results from pathology of the vascular
or perivascular tissues. (p. 168)
Visceral pain Pain that originates from internal organs or
smooth muscles. (p. 166)
HIGH-ALERT DRUGS
codeine (codeine sulphate), p. 178
fentanyl (fentanyl citrate), p. 178
lidocaine, transdermal, p. 184
meperidine (meperidine hydrochloride), p. 179
methadone (methadone hydrochloride), p. 179
morphine (morphine sulphate), p. 178
oxycodone (oxycodone hydrochloride), p. 180
tramadol (tramadol hydrochloride), p. 183
166
PART 2 Drugs Affecting the Central Nervous System
OVERVIEW
The management of pain is an important aspect of nursing care
in a variety of settings and across the lifespan. Pain is one of
the most common reasons that patients seek health care and
is the underlying reason for 78% of emergency department
visits annually in Canada. Surgical and diagnostic procedures
often require pain management, as do several diseases, including arthritis, diabetes, multiple sclerosis, cancer, and acquired
immune deficiency syndrome (AIDS). Pain leads to much suffering and is a tremendous economic burden as a result of lost
workplace productivity, workers’ compensation payments, and
other related health care costs.
To provide quality patient care, it is important to be well
informed about both pharmacological and nonpharmacological
methods of pain management. This chapter focuses on pharmacological methods of pain management. Some examples of nonpharmacological methods of pain management are listed in Box 11.1.
Medications that relieve pain are classified as analgesics.
They are also commonly referred to as painkillers. There are
various classes of analgesics, determined by their chemical
structures and mechanisms of action. The focus of this chapter
is primarily on the opioid analgesics, which are used to manage moderate to severe pain. Often drugs from other chemical categories are added to the opioid regimen as adjuvant
analgesic drugs (or adjuvants), and these are described later.
Pain is most commonly defined as an unpleasant sensory and
emotional experience associated with either actual or potential
tissue damage. It is a personal and individual experience. Pain
can be defined as whatever the patient says it is, and it exists
whenever the patient says it does. Although the mechanisms of
pain are becoming better understood, a patient’s perception of
pain is a complex process. Pain involves physical, psychological,
and ethnocultural factors (see Ethnocultural Implications box:
The Patient Experiencing Pain: Considerations From a Holistic
Perspective). Because pain intensity cannot be precisely quantified, health care providers must cultivate relationships of mutual
trust with their patients to provide optimal care.
There is no single approach to effective pain management.
Instead, it is tailored to each patient’s needs. The cause of the
pain, the existence of concurrent medical conditions, the characteristics of the pain, and the psychological and ethnocultural
characteristics of the patient all need to be considered. It also
requires ongoing reassessment of the pain and the effectiveness
of treatment. The patient’s emotional response to pain depends
on the individual psychological experience of pain. Pain results
from the stimulation of sensory nerve fibres known as nociceptors. These receptors transmit pain signals from various body
regions to the spinal cord and brain, which leads to the sensation of pain, or nociception (Fig. 11.1). Nociceptive pain is
transitory in response and serves an important protective role.
There are two subtypes of nociceptive pain: visceral pain (pain
originating from skeletal muscles, ligaments, or joints) and
somatic pain (pain originating from internal organs or smooth
muscles).
ETHNOCULTURAL IMPLICATIONS
The Patient Experiencing Pain: Considerations
From a Holistic Perspective
• Pain is experienced by individuals, not by a culture. Health care providers
often interpret pain behaviour through their own cultural lens and often
make assumptions about patients by the behaviours they display.
• Know that there are environmental and ethnocultural variations in pain
experience and expression and in health care–seeking treatment.
• Recognize the contributions and limitations of the social determinants of
health to pain experience, pain expression, and treatment access.
• Know that pain behaviours and reports are best understood in the context
of social interactions among the individual, family, employers, and health
care providers and in the context of community, governmental, or legal procedures.
• Be aware of communication about cultural and religious variation that
health care providers should consider when assessing and managing pain.
• Recognize that social environmental factors, including the individual’s
beliefs about the origins and nature of pain and how one should access
health care, can influence both experiential and expressive features of pain.
• Recognize the internal and exogenous barriers that impact access to the
implementation of pain evaluation and treatment (e.g., individual motivation, beliefs, adverse effects, availability of opioids).
• Remain aware of all ethnocultural influences on health-related behaviours
and on patients’ attitudes toward medication therapy and thus, ultimately,
on its effectiveness. A thorough assessment that includes questions about
the patient’s cultural background and practices is important to the effective
and individualized delivery of nursing care.
Nonpharmacological Treatment
Options for Pain
BOX 11.1
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Acupressure
Acupuncture
Art therapy
Behavioural therapy
Biofeedback
Comfort measures
Counselling
Distraction
Hot or cold packs
Hypnosis
Imagery
Massage
Meditation
Music therapy
Pet therapy
Physiotherapy
Reduction of fear
Relaxation
Surgery
Therapeutic baths
Therapeutic communication
Therapeutic touch
Transcutaneous electrical nerve stimulation
Warming cabinets/warm blankets
Yoga
CHAPTER 11 Analgesic Drugs
3
167
3 PERCEPTION
OF PAIN
2 TRANSMISSION
The pain
impulse
moves from the
spinal cord to
the brain.
Spinothalamic
tract neuron
2
Opioid
receptors
4 MODULATION
Nociceptor
Neurons from
brainstem
release
neurotransmitters
that block the
pain impulse.
Neuron
from
brainstem
4
1
Nociceptor
1 TRANSDUCTION
Noxious stimuli
Spinothalamic
tract neuron
• Injured tissue releases
chemicals that
propagate pain message.
• Action potential moves
along an afferent fibre
to the spinal cord.
Na+ Na+- Na+ +
+
+ +
Nociceptor
+
+
+
+
+
+
+
K+
K+
-
+
+
-
-
Opioid
receptors
+
+
+
+
Na+
Na+
+
Na
-
-
Fig. 11.1 Illustration of the four processes of nociception. (Source: Jarvis C., Browne, A. J., MacDonaldJenkins, J., et al. (2014). Physical examination and health assessment (Canadian 2nd ed.) St Louis, MO:
Saunders.)
The physical impulses that signal pain activate various nerve
pathways from the periphery to the spinal cord and to the brain.
The level of stimulus needed to produce a painful sensation is
referred to as the pain threshold. Because this is a measure of
the physiological response of the nervous system, it is similar
for most people. However, variations in pain sensitivity may
result from genetic factors.
There are three main receptors believed to be involved in
pain. The µ (mu) receptors in the dorsal horn of the spinal
cord appear to play the most crucial role. Less important but
still involved in pain sensations are the κ (kappa) and δ (delta)
receptors. Pain receptors are located in both the central nervous
system (CNS) and various body tissues. Pain perception—and,
conversely, emotional well-being—is closely linked to the number of µ (mu) receptors. This number is controlled by a single
gene, the µ (mu) opioid receptor gene. When the number of
receptors is high, pain sensitivity is diminished. Conversely,
when the receptors are reduced or missing altogether, relatively
minor noxious stimuli may be perceived as painful.
The patient’s emotional response to the pain is also moulded
by the patient’s age, gender, culture, previous pain experience,
and anxiety level. Whereas pain threshold is the physiological
element of pain, the psychological element of pain is called pain
tolerance. This is the amount of pain a patient can endure without its interfering with normal function. Because it is a subjective response, pain tolerance can vary from patient to patient.
TABLE 11.1
Tolerance
Conditions That Alter Pain
Pain Threshold
Conditions
Lowered
Anger, anxiety, depression, discomfort, fear, isolation, persistent pain, sleeplessness, tiredness
Diversion, empathy, rest, sympathy, medications
(analgesics, antianxiety drugs, antidepressants)
Raised
Pain tolerance can be modulated by the patient’s personality,
attitude, environment, culture, and ethnic background. Pain
tolerance can even vary within the same person depending on
the circumstances involved. Table 11.1 lists the various conditions that can alter one’s pain tolerance.
Pain can also be further classified in terms of its onset
and duration as either acute or persistent. Acute pain is sudden and usually subsides when treated. One example of acute
pain is postoperative pain. Persistent pain (also referred to as
chronic or long-term pain) is recurring, lasting 3 to 6 months.
It is often more difficult to treat, because changes occur in the
nervous system that often require increasing drug dosages (see
Evidence in Practice: Student Nurses’ Misconceptions of Adults
With Chronic Nonmalignant Pain Review box). This situation
is known by the general term tolerance. Tolerance is the state of
progressively decreased responsiveness to a drug as a result of
which a larger dose of the drug is needed to achieve the effect
168
PART 2 Drugs Affecting the Central Nervous System
EVIDENCE IN PRACTICE
Student Nurses’ Misconceptions of Adults With Chronic Nonmalignant Pain Review
The purpose of this study was to identify some of the misconceptions that student nurses have, across 3 years of undergraduate education, about adults who
are experiencing chronic, nonmalignant pain. The two major questions that this
study sought to explore were as follows: (1) Do student nurses hold misconceptions about adults with chronic, nonmalignant pain? and (2) if so, to what extent
do these misconceptions develop during their undergraduate education?
Results of Study
Some 435 students were approached to participate in the research study, and
430 completed and returned the surveys, for a total response rate of 99%. A
convenience sampling was used because the students were easily accessible;
they represented about 75% of students enrolled in the facility in semesters one,
four, and six of the undergraduate nursing degree program in the city of Auckland
and around 13% of those enrolled in New Zealand. These participants were
distributed over a 3-year period of undergraduate studies during six semesters
of full-time studies. The majority were female students, although there was no
further specific demographic data collected about the participants. A cross-sectional design meant that data gathered came from each participant only once
during the study. A research assistant—one who had not taught the students—
met with the students and invited them to participate in the study. Sessions
were held in the middle of the semester to increase the response rate as well
as diminish anxiety during final exam time. More than 38% of the participants
demonstrated a misconception about people with chronic pain and that people
were tolerant to some degree of pain. More than 60% did not hold this misconception about tolerance to pain. More than one-half of the students’ (59%)
responses indicated that they held the misconception that psychological impairment results from chronic pain. Approximately 79% of the students suggested
that they believed stress was a contributory cause of chronic pain, whereas less
than one-fourth indicated that they accurately understood that this was not the
case. The misconception of compensation and exaggeration in chronic pain was
held by 47.9% of the participants, and 51.7% did not hold this same misconception. About one-third of the students indicated that they held the misconception
that patients with chronic pain were manipulative, and the majority indicated
that they did not.
Approximately 64% of the participants held the misconception that depression
plays a role in the chronic pain experience. About one-half of the participants
(54.8%) held the misconception that patients taking opioids were likely to be
addicted. Some 58% of the students indicated that they held the misconception that patients with chronic pain were noncompliant and dependent, whereas
41.4% indicated that they did not hold this misconception. Another question
posed to the students was about the extent to which they had developed their
misconceptions of patients with chronic pain during their undergraduate education. There were significantly positive trends across the semesters, suggesting
that students held their misconceptions to a lesser degree as they progressed
through their course of study. In summary, analysis of the results indicates that
a substantial proportion of students who participated in the study hold misconceptions about patients with chronic pain to some extent.
The analysis of the misconception scores across the semesters indicates that
the knowledge and attitudes of students toward adults experiencing chronic,
nonmalignant pain developed to some degree because their misconceptions
were held to a lesser degree by the end of the program of study.
Link of Evidence to Nursing Practice
It is a known phenomenon that there is a gap between theory and practice across
many areas of professional nursing practice. Therefore, it would be ideal for
nursing educators and the nursing educational experience to equip students with
the knowledge, skills, and attitudes to participate in the discussion, planning,
and implementation of care for patients suffering from chronic, nonmalignant
pain. Nursing faculty and schools of nursing need to make available experiential
learning situations that will enhance the blending of knowledge, skills, and attitudes into professional nursing practice so that these gaps in care are closed.
The findings of this study show that students, like many practising nurses, hold
misconceptions about adults with chronic, nonmalignant pain, representing a
lack of knowledge and inappropriate attitudes. An integrated approach to teaching chronicity and disability needs to be included in the nursing curriculum; however, critical thinking, linking theory to practice, and developing compassion also
need to be part of the educational process.
Shaw, S., & Lee, A. (2010). Student nurses’ misconceptions of adults with chronic malignant pain. Pain Management Nursing, 11(1), 2–14.
originally obtained by a smaller dose (see Chapter 18). Acute
and persistent pain differ in their onset and duration, their associated diseases or conditions, and the way they are treated. Table
11.2 lists the different characteristics of acute and persistent
pain and various diseases and conditions associated with each.
Pain can be further classified according to the diseases or
conditions that cause it. Vascular pain is believed to originate
from the vascular or perivascular tissues and is thought to
account for a large percentage of migraine headaches. Referred
pain occurs when visceral nerve fibres synapse at a level in the
spinal cord close to fibres that supply specific subcutaneous tissues in the body. An example is the pain associated with cholecystitis, which is often referred to the back and scapular areas.
Neuropathic pain usually results from damage to peripheral or
CNS nerve fibres by disease or injury but may also be idiopathic
(unexplained). Phantom pain occurs in the area of a body
part that has been removed—surgically or traumatically—and
is often described as burning, itching, tingling, or stabbing. It
can also occur in paralyzed limbs following spinal cord injury.
TABLE 11.2
Type of
Pain
Acute
Persistent
Onset
Acute Versus Persistent Pain
Duration
Sudden (minutes to
Limited (has an
hours); usually sharp, end)
localized; physiological response (SNS:
tachycardia, sweating, pallor, increased
blood pressure)
Slow (days to months); Long-lasting
long duration; dull,
or recurring
long-lasting, aching
(endless)
Examples
Myocardial infarction,
appendicitis, dental
procedures, kidney
stones, surgical
procedures
Arthritis, cancer,
lower back pain,
peripheral neuropathy
SNS, Sympathetic nervous system.
Cancer pain can be acute or persistent or both. It most often
results from pressure of the tumour mass against nerves, organs,
or tissues. Other causes of cancer pain include hypoxia from
CHAPTER 11 Analgesic Drugs
169
Central
processing
Spinal
column
(vertebrae)
Dorsal side (posterior)
Large A-fibre
Inhibition
Brain
Pain perception
Spinal cord (CNS)
Dorsal (posterior) horn
From
peripheral
nerve
Small C-fibre
endings
“Gate”
Endorphins/enkephalins
Opiate receptor
Ventral (anterior) horn
Ventral side (anterior)
Spinal column (vertebrae)
Fig. 11.2 Gate control theory of pain transmission. CNS, central nervous system.
blockage of blood supply to an organ; metastases; pathological fractures; muscle spasms; and adverse effects of radiation,
surgery, and chemotherapy. Central pain occurs with tumours,
trauma, inflammation, or disease (e.g., cancer, diabetes, stroke,
multiple sclerosis) affecting CNS tissues.
Over the course of history, the concept of pain has been
influenced by the current knowledge at the time. The most common and well described is the gate control theory, proposed
by Melzack and Wall in 1965. This theory explains the mechanism underlying the alteration of somatosensory afferents that
act like a “gate” that is able to adjust pain signals transmitted
from the periphery. Four distinct processes, all of which operate
simultaneously, are required for nociceptive pain to occur and
are widely believed to determine the perception of and response
to acute pain.
The first process, transduction, corresponds to the transformation of mechanical, chemical, or thermal stimuli into electrochemical energy. At first, tissue injury prompts the release of
numerous chemicals such as prostaglandins, bradykinin, serotonin, substance P, histamine, and potassium from injured cells.
Some current pain medications work by altering the actions and
levels of these substances (e.g., nonsteroidal anti-inflammatory
drugs [NSAIDs] target prostaglandins; antidepressants target
serotonin). The release of these pain-mediating chemicals initiates action potentials (electrical nerve impulses), at the distal
end of sensory nerve fibres, through pain receptors known as
nociceptors. These nerve impulses are conducted along sensory
nerve fibres and activate pain receptors in the dorsal horn of the
spinal cord. This is where the so-called gates are located. These
gates regulate the flow of sensory nerve impulses. If impulses
are stopped by a gate at this junction, no impulses are transmitted to the higher centres of the brain. Conversely, if the gates
permit a sufficient number and intensity of action potentials to
be conducted from the spinal cord to the cerebral cortex, the
sensation of pain is then felt. This is known as nociception. Fig.
11.2 depicts the gate control theory of pain transmission.
170
PART 2 Drugs Affecting the Central Nervous System
TABLE 11.3
A and C Nerve Fibres
Type of
Fibre
Myelin
Sheath
Conduction
Fibre Size Speed
Type of Pain
A
Yes
Large
Fast
C
No
Small
Slow
Sharp and well
localized
Dull and nonlocalized
The second process, transmission, involves the propagation
of pain impulses along pain fibres, as well as other sensory
nerve fibres, to activate pain receptors in the spinal cord and
brain. There are two types of nociceptor pain fibres: large-diameter A-delta fibres and small-diameter C fibres (Table 11.3).
The A-delta fibres constitute the majority of myelinated fibres
responsible for the first pain sensation. There are two types of
A-delta fibres, which are triggered by the specificity of their
responses to different stimulation: the mechanonociceptors
respond to intense and possibly harmful stimulation (flight or
fight response) and the polymodal A-delta fibres respond to
mechanical, thermal, and chemical stimulation. The C fibres are
unmyelinated and transmit poorly localized, dull, and aching
pain.
The majority of nociceptive impulses travel through the
anterolateral quadrant of the spinal cord. The spinothalamic
tract is the most important pathway for transmission. The nociceptive fibres enter the spinal cord through an area known as the
dorsal (posterior) horn. Here, the neurotransmitters glutamate
and substance P continue the pain impulse across the synaptic
cleft between nociceptors and dorsal horn neurons. From the
dorsal horn, numerous different ascending fibre tracts within
the larger spinothalamic tract transmit pain into the thalamus,
where the integration of nociceptive information takes place.
From the thalamus, the pain impulses are relegated to the cortical structures for pain.
It is at the dorsal horn that the so-called gates are located
and where they control pain transmission. Closing of the gate
seems to be affected by the activation of A fibres. This causes
the inhibition of impulse transmission to the brain and avoidance of pain sensation. Opening of the gate is affected by the
stimulation of C fibres. This allows impulses to be transmitted
to the brain and pain to be sensed. The gate is innervated by
nerve fibres that originate in the brain and modulate the pain
sensation by sending impulses to the gate in the spinal cord.
These nerve fibres enable the brain to evaluate, identify, and
localize the pain. Thus, the brain can control the gate, either by
keeping the gate closed or allowing it to open so that the brain
is stimulated and pain is sensed. The cells that control the gate
have a threshold. Impulses that reach these cells must rise above
this threshold before an impulse is permitted to travel up to the
brain.
The third process involved in nociceptive pain, perception, is
less an actual physiological event than a subjective phenomenon
of pain (how it feels) that encompasses complex behavioural,
psychological, and emotional factors. An identical stimulus can
evoke different types of pain from one individual to another.
The µ (mu) receptors in the dorsal horn appear to play a crucial role. Pain perception and, conversely, emotional well-being,
are closely linked to the number of µ receptors. Pain sensitivity
is diminished when the receptors are present in relative abundance. When the receptors are reduced in number or missing
altogether, relatively minor noxious stimuli may be perceived
as painful.
Modulation is the fourth process. Modulation is a neural
activity that controls pain transmission to neurons in both the
peripheral and central nervous systems. The pathways involved
are referred to as the descending pain system because the neurons originate in the brainstem and descend to the distal horn
of the spinal cord. The descending nerve fibres release endogenous neurotransmitters known as enkephalins and endorphins
(e.g., endogenous opioids, serotonin [5-HT], norepinephrine
[NE], gamma-aminobutyric acid [GABA], neurotensin). These
substances are produced within the body to fight pain and are
considered the body’s painkillers. Both types of substances are
capable of binding with opioid receptors and inhibiting the
transmission of pain impulses by closing the spinal cord gates,
in a manner similar to that used by opioid analgesic drugs to
produce analgesia. Both are capable of bonding with opioid
receptors and inhibiting the transmission of pain impulses by
closing the spinal cord gates. The term endorphin is a condensed
version of the term endogenous morphine. These endogenous
analgesic substances are released whenever the body experiences pain or prolonged exertion. For example, they are responsible for the phenomenon of “runner’s high.” Fig. 11.1 depicts
this entire process.
Another phenomenon of pain relief that may be explained
by the gate control theory is the fact that massaging a painful
area often reduces the pain. When an area is rubbed or liniment
applied, large sensory A nerve fibres from peripheral receptors
carry pain-modulating impulses to the spinal cord. Remember,
the A fibres cause impulse transmission to be inhibited and the
gate to be closed. This action, in turn, reduces the recognition of
the pain impulses arriving by means of the small fibres.
TREATMENT OF PAIN IN SPECIAL SITUATIONS
It is estimated that one of every five Canadians experiences persistent pain. Pain is poorly understood and often undertreated.
In addition to enduring their baseline persistent pain, patients
with illnesses such as cancer, AIDS, and sickle cell anemia may
also experience crisis periods of acute pain. Effective management of acute pain is often different from management of persistent pain in terms of medications and dosage used. Routes
of drug administration may include oral, intravenous (IV),
intramuscular (IM), subcutaneous (subcut), transdermal, and
rectal. One IV route commonly used in the hospital setting is
patient-controlled analgesia (PCA). In this situation, patients
are able to self-medicate by pressing a button on a PCA infusion
pump. This method has been shown to be effective and reduces
the total opioid dose used. Morphine sulphate and fentanyl are
commonly given by PCA.
CHAPTER 11 Analgesic Drugs
Patients with complex pain syndromes often benefit from a
holistic clinical or multimodal clinical approach that involves
pharmacological or nonpharmacological treatment or a combination of both. The goals of pain management include reducing
and controlling pain and improving body function and quality
of life.
In situations such as pain associated with cancer, the main consideration in pain management is patient comfort and not trying
to prevent addiction (or psychological dependence; see Chapter
18) to the pain medication. Opioid tolerance is a state of adaptation in which exposure to a drug causes changes in drug receptors
that result in reduced drug effects over time. This phenomenon can
occur in as little as one week. Because of increasing pathology (e.g.,
tumour burden), patients with cancer usually require increasingly
higher opioid doses and thus do become physically dependent on
the drugs. Patients with cancer are likely to experience withdrawal
symptoms (see Chapter 18) if opioid doses are abruptly reduced or
discontinued; however, actual psychological dependence or addiction in such patients is unusual. For long-term pain control, oral,
IV, subcut, transdermal, and sometimes even rectal dosing routes
are favoured over multiple IM injections due to associated puncture trauma (bruising) and erratic drug absorption.
One controversial issue in pain management is the use of
placebos, inert dosage forms that lack medication. Some health
care providers feel that this practice may be helpful by taking
advantage of the well-documented placebo effect—a psychological therapeutic effect that occurs even in the absence of actual
medication. It is believed to arise from activation of the patient’s
own endorphins. It is also attributed to the patient’s belief that
any “treatment” is effective, as well as the patient’s high level
of trust in the health care provider. Critics argue that the use
of placebos is unethical, because it requires that the patient be
deceived in the process. The use of placebos for pain management has fallen out of favour, and they are rarely used today (see
Chapter 3 for further discussion).
The treatment of acute pain in patients who are addicted
to opioids is of great concern to clinicians, who may be reluctant to prescribe opioid therapy. However, habitual opioid
users are opioid tolerant and generally require high dosages.
Longer-acting opioids such as methadone or extended-release oxycodone are usually better choices than shorter-acting
immediate-release drug products for these patients. Genetic
differences in cytochrome P450 enzymes (see Chapters 4 and
5) can impact how effectively different patients, with or without
an addiction, respond to a given drug. For this reason, patients
must not automatically be viewed with suspicion if they report
that a given drug does not work for them.
Health care providers may unfairly use the label of addict to
justify refusal to prescribe pain medications, resulting in undertreatment of pain, even in patients who do not use street drugs.
This is now regarded as an inappropriate and inhumane clinical
practice. In these situations, control of the patient’s pain takes
ethical and clinical priority over concerns regarding drug addiction. Nonetheless, health care providers must contend with the
reality of patients’ misuse of street or prescription drugs (see
Chapter 18). Such patients often request excessive numbers of
171
prescriptions and may use multiple health care providers or
pharmacies. At times, they may also forge prescriptions or call
in prescriptions by phone for opioid pain relievers such as those
containing oxycodone, hydromorphone, fentanyl, morphine,
and codeine. Community pharmacists work collaboratively
to detect such abuses and notify law enforcement authorities.
Creating a phony prescription for a controlled substance is a
felony.
For patients receiving long-acting opioid analgesics, breakthrough pain often occurs between doses of pain medications. This is because the analgesic effects wear off as the drug
is metabolized and eliminated from the body. Treatment with
prn (as needed) doses of immediate-release dosage forms (e.g.,
oxycodone IR), given between scheduled doses of extended-release dosage forms (e.g., oxycodone ER), is often helpful in these
cases. Chewing or crushing of any extended-release opioid drug
can cause oversedation, respiratory depression, and even death
due to rapid drug absorption. If the patient is requiring larger
doses for breakthrough pain, the dose of the scheduled extended-release opioid may need to be increased, administered more
frequently, or changed to a more potent opioid.
Drugs from other chemical categories are often added to
the opioid regimen as adjuvant drugs. These assist the primary
drugs in relieving pain. Such adjuvant drug therapy may include
NSAIDs (see Chapter 49), antidepressants (see Chapter 17),
antiepileptic drugs (see Chapter 15), and corticosteroids (see
Chapter 50), all of which are discussed further in their corresponding chapters. This approach allows the use of smaller dosages of opioids and reduces some of the adverse effects that are
seen with higher dosages of opioids, such as respiratory depression, constipation, and urinary retention. It permits drugs with
different mechanisms of action to produce synergistic effects.
Antiemetics (see Chapter 41) and laxatives (see Chapter 40)
may also be needed to prevent or relieve associated constipation, nausea, and vomiting (Table 11.4).
One common use of adjuvant drugs is in the treatment of neuropathic pain. Opioids are not completely effective in such cases.
Neuropathic pain usually results from nerve damage secondary to
disease (e.g., diabetic neuropathy, postherpetic neuralgia secondary to shingles, trigeminal neuralgia, AIDS, or injury, including
nerve damage secondary to surgical procedures [e.g., post-thoracotomy pain syndrome occurring after cardiothoracic surgery]).
Common symptoms include hypersensitivity or hyperalgesia to
mild stimuli such as light touch or a pinprick, or the bed sheets
on a person’s feet. This phenomenon is also known as allodynia. It
can also manifest as hyperalgesia to uncomfortable stimuli, such as
pressure from an inflated blood pressure cuff on a patient’s limb. It
may be described as heat, cold, numbness and tingling, burning,
or electrical sensations. Examples of adjuvants commonly used in
these cases are the antidepressant amitriptyline hydrochloride and
the anticonvulsants gabapentin and pregabalin.
The three-step analgesic ladder proposed by the World
Health Organization (WHO) (Fig. 11.3) is often applied as
the pain management standard for cancer pain and to meet
the therapeutic challenges presented by opioid tolerance.
In 2019, the WHO developed the WHO Guidelines for the
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PART 2 Drugs Affecting the Central Nervous System
TABLE 11.4
Potential Opioid Adverse Effects and Their Management
Adverse Effect
Preventive Measures
Constipation
Opioids decrease gastrointestinal tract peristalsis because of their central
nervous system (CNS) depression, with subsequent constipation as an
adverse effect. Stool becomes excessively dehydrated because it remains
in the gastrointestinal tract longer.
Nausea and Vomiting
Opioids decrease gastrointestinal tract peristalsis, and some also
stimulate the vomiting centre in the CNS, so nausea and vomiting
are often experienced.
Sedation and Mental Clouding
Any change in mental status should always be evaluated to ensure that
causes other than drug-related CNS depression are ruled out.
Respiratory Depression
Long-term opioid use is generally associated with tolerance to respiratory
depression.
Subacute Overdose
Subacute overdose may be more common than acute respiratory
depression and may progress slowly (over hours to days), with
somnolence and respiratory depression. Before analgesic dosages are
changed or reduced, advancing disease must be considered,
especially in patients who are dying.
Constipation may be managed with increased intake of fluids; or the use of
stimulants such as bisacodyl or senna; and the use of agents such as lactulose,
sorbitol, and polyethylene glycol (Clearlax®) solution. Less commonly used are
bulk-forming laxatives such as psyllium, for which increased fluid intake is especially important to avoid fecal impactions or bowel obstructions. Ambulation is
also a method of promoting bowel movement.
Nausea and vomiting may be managed with the use of antiemetics such as
phenothiazines.
Persistent drug-related sedation may be managed with a decrease in the dose
of opioid or a change in the drug used. The health care provider may also order
various CNS stimulants (see Chapter 14).
For severe respiratory depression, opioid antagonists (naloxone hydrochloride) may
be used to improve respiratory status and, if they are titrated in small amounts,
the respiratory depression may be reversed without analgesia reversal.
Often, holding one or two doses of an opioid analgesic is enough to judge if the
mental and respiratory depression is associated with the opioid. If there is
improvement with this measure, the opioid dosage is often decreased by 25%.
Opioid-Induced Hyperalgesia (OIH)
Prolonged use of opioids such as morphine sulphate can cause a paradoxical
effect, where the patient develops a heightened sensitivity (hyperalgesia)
to noxious stimuli. At times, this may even evolve to a painful response to
non-noxious stimuli (allodynia).
Once OIH is diagnosed, the most straightforward intervention is to lower the
opioid slowly to minimize withdrawal symptoms. If the patient still requires
some amount of analgesia, then titrating to reduce the dose has been found
successful.
Other Opioid Adverse Effects
Dry mouth, urinary retention, pruritus, myoclonus, dysphoria, euphoria, sleep
disturbances, sexual dysfunction, and inappropriate secretion of antidiuretic
hormone may occur but are less common than the aforementioned adverse
effects.
Ongoing assessment is needed for each adverse effect so that appropriate
measures may be implemented (e.g., sucking of sugar-free hard candy or use of
artificial saliva drops or gum for dry mouth; use of diphenhydramine hydrochloride for pruritus).
Pharmacological and Radiotherapeutic Management of Cancer
Pain in Adults and Adolescents (see https://www.who.int/ncds/
management/palliative-care/cancer-pain-guidelines/en/ for
information). Examples of nonopioid analgesic drugs include
NSAIDs (see Chapter 49) as well as acetaminophen and tramadol hydrochloride (see Drug Profiles box). Step 1 is the use
of nonopioids (with or without adjuvant medications), once
the pain has been identified and assessed. If pain persists or
increases, treatment moves to step 2, which is defined as the
use of opioids with or without nonopioids and with or without
adjuvants. Should pain persist or increase, management then
rises to step 3, which is the use of opioids indicated for moderate to severe pain, administered with or without nonopioids
or adjuvant medications. The goal for patients, as confirmed by
the WHO, is freedom from pain.
OPIOID DRUGS
Opioids are classified as both mild agonists (e.g., codeine,
hydrocodone bitartrate) and strong agonists (e.g., morphine,
hydromorphone hydrochloride, oxycodone, meperidine,
fentanyl, methadone). Meperidine is not recommended for
long-term use because of the accumulation of a neurotoxic
metabolite, normeperidine. In fact, most hospitals restrict the
use of meperidine as a result of adverse events such as neurotoxicity from the normeperidine metabolite, delirium in
older adult patients, and serotonin syndrome. Opiate agonist–antagonists such as pentazocine are associated with an
analgesic ceiling effect. This means that the drug reaches a
maximum analgesic effect, so that analgesia does not improve
even with higher dosages (see Drug Profiles box). Such drugs
CHAPTER 11 Analgesic Drugs
m pain
Opioids
moderate to for
severe
± Nonopioid pain
± Adjuvant
Pain pers
isting or
Opioids
ersisti
Nonop
ioids ±
ng or in
Opioids
3
Chemical Category
Opioid Drugs
morphine-like drugs
morphine, heroin, hydromorphone, codeine,
hydrocodone, oxycodone
meperidine, fentanyl, remifentanil, sufentanil, alfentanil
methadone
tramadol, tapentadol
meperidine-like drugs
increasin
g
for mild
to m
± Nonop oderate pain
ioid
± Adjuva
nt
Pain p
Chemical Classification of
TABLE 11.5
Freedom fro
2
creasin
g
methadone-like drugs
Other
TABLE 11.6
Characteristics
Adjuva
nt
1
Fig. 11.3 Three-step analgesic ladder. Source: World Health Organization. (2008). WHO’s pain ladder. Retrieved from http://www.who.int/
cancer/palliative/painladder/en/.
are useful only in patients who have not been previously
exposed to opioids and can be used for non-escalating, moderate to severe pain. Finally, because of associated bruising and
bleeding risks, as well as injection discomfort, there is now
a strong trend away from IM injections in favour of IV, subcut (e.g., via a subcutaneous butterfly), oral, and transdermal
routes of drug administration.
The synthetic pain-relieving drugs currently known as opioid analgesics originated from the opium poppy plant. Natural
opioids containing or derived from opium are known as opiate
analgesics. The word opium is a Greek word that means “juice.”
More than 20 different alkaloids are obtained from the unripe
seed of the poppy plant. The properties of opium and its many
alkaloids have been known for centuries. Opium-smoking
immigrants brought opium to Canada, where unrestricted
availability of opium prevailed until the early twentieth century.
Chemical Structure
Opioid analgesics are strong pain relievers. They can be classified
according to their chemical structure or their action at specific receptors. Of the 20 different natural alkaloids available from the opium
poppy plant, only three are clinically useful: morphine, codeine, and
papaverine. Of these three, only morphine and codeine are pain
relievers; papaverine is a smooth muscle relaxant. Relatively simple
chemical modifications of these opium alkaloids have produced the
three different chemical classes of opioids: morphine-like drugs,
meperidine-like drugs, and methadone-like drugs (Table 11.5).
Mechanism of Action and Drug Effects
Opioid analgesics can also be characterized according to their
mechanism of action. They are agonists or agonist–antagonists.
An agonist binds to an opioid pain receptor in the brain and
causes an analgesic response—the reduction of pain sensation.
173
Opioid Receptors and Their
Receptor Type
Prototypical Agonist Effects
µ (mu)
morphine
κ (kappa)
butorphanol tartrate
δ (delta)
enkephalins
Supraspinal analgesia,
respiratory depression,
euphoria, sedation*
Spinal analgesia, sedation, †miosis
Analgesia
*Moderate level of sedation.
†Twice as much sedation compared to µ (mu) receptors.
An agonist–antagonist (e.g., pentazocine), also called a partial agonist, binds to a pain receptor and causes a weaker pain
response than a full agonist does. Different drugs in this class
exert their agonist or antagonist effects by binding in different
degrees to κ (kappa) and µ (mu) opioid receptors. Although not
normally used as first-line analgesics, they are sometimes useful in pain management in patients who are addicted to opioids
as well as in obstetrical patients (because they avoid oversedation of the mother and fetus). Antagonists (e.g., naloxone) are
non-analgesics that bind to pain receptors but do not reduce
pain signals. They function as competitive antagonists because
they compete with and reverse the effects of agonist and agonist–antagonist drugs at the receptor sites.
The receptors to which opioids bind to relieve pain are listed
in Table 11.6. The µ (mu), κ (kappa), and δ (delta) receptors
are the most responsive to drug activity, with the µ (mu) being
the most important. Many of the characteristics of a particular
opioid, such as its ability to sedate, its potency, and its ability
to cause hallucinations, can be attributed to relative affinity for
these various receptors.
Understanding the relative potencies of various drugs
becomes important in clinical settings. Equianalgesia refers
to the ability to provide equivalent pain relief by calculating
dosages of different drugs or routes of administration that
provide comparable analgesia. Because fentanyl is most commonly used transdermally, it is discussed separately in its drug
profile.
Indications
The main use of opioids is to alleviate moderate to severe
pain. The amount of pain control or unwanted adverse
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PART 2 Drugs Affecting the Central Nervous System
PREVENTING MEDICATION ERRORS
Fentanyl Transdermal Patches
When applying fentanyl (Duragesic Mat®) transdermal patches, the nurse
needs to keep in mind several important points to avoid improper administration:
• These patches are recommended to be used only by patients who are considered opioid tolerant. To be considered opioid tolerant, a patient should
have been taking, for a week or longer, morphine 60 mg daily, oral oxycodone
30 mg daily, or oral hydromorphone 8 mg daily (or an equianalgesic dose of
another opioid). Applying fentanyl transdermal patches to non–opioid-tolerant patients may result in severe respiratory depression. Thorough assessment is important.
• Inform patients that heat, such as a sauna, hot tub, heating pad, or heating
pack must never be applied over a fentanyl transdermal patch. The increased
circulation from the application of heat may result in increased absorption of
medication, causing an overdose.
• Teach patients to avoid the use of soap, alcohol, or other solvents on the skin
surface where the patch is to be applied as these products may enhance the
drug’s ability to penetrate the skin. Recommend the use of plain water to
wash the area. After applying or removing the patch, wash hands with water
only.
effects depends on the specific drug, the receptors to which
it binds, and its chemical structure. Strong opioid analgesics
such as fentanyl, sufentanil, and alfentanil are commonly
used in combination with anaesthetics during surgery. These
drugs are used not only to relieve pain but also to maintain
a balanced state of anaesthesia. The practice of using combinations of drugs to produce anaesthesia is referred to as
balanced anaesthesia (see Chapter 12). Use of fentanyl injection for management of postoperative and procedural pain
has become popular because of its rapid onset and short
duration. Transdermal fentanyl is available in a patch formulation for use in long-term pain management and is not to
be used for postoperative pain or any other short-term pain
control (see Preventing Medication Errors box: Fentanyl
Transdermal Patches).
Strong opioids such as morphine, meperidine, hydromorphone, and oxycodone are often used to control postoperative
and other types of pain. Because morphine and hydromorphone
are available in injectable forms, they are often first-line analgesics in the immediate postoperative setting. There is a trend
away from using meperidine due to its greater potential for toxicity (see Drug Profile). All available oxycodone dosage forms
are orally administered. The brand name product OxyContin is
a sustained-release form of oxycodone that contains more oxycodone hydrochloride than the immediate-release formulation,
with the intent to last up to 12 hours. The “Contin” in the product name stands for “continuous release,” a synonym for long
action in any drug product. If the tablet is chewed, crushed, or
dissolved, however, the medication is released all at once. This
may occur accidentally, or it may be done deliberately to achieve
a euphoric high. Once crushed, the drug can also be snorted or
injected. Due to this abuse and the increase in the number of
addicted individuals, this formulation was removed from the
• Teach patients that fentanyl patches should not be cut under any circumstances.
• Teach patients about the proper disposal of transdermal patches. Children
have pulled used patches from the trash, which has resulted in deaths
because of exposure to the drug. For disposal at home, the product insert
recommends that the patch be folded so that the adhesive side of the system adheres to itself and then disposed of by flushing down the toilet. However, disposal practices may vary by area because of concerns for the water
systems. Disposal policies in facilities also vary, but some require that used
patches be placed in a sharps container rather than be flushed.
• Keep patches, as well as all medications, away from children and pets. Do
not store medications in warm, moist places such as medicine cabinets in the
bathroom.
The Institute for Safe Medication Practices has described examples of fatal
patient incidents resulting from failure to follow the above points. It is essential
for patients’ safety to read the product labelling and follow instructions precisely. For more information, go to https://www.ismp-Canada.org.
Canadian market. It has been replaced with OxyNeo®, a formulation designed to reduce misuse; when the drug is crushed and
combined with water, it becomes gel-like and difficult to inject.
The drug product MS Contin® is a long-acting or sustained-release form of morphine that is also designed to provide 8 to 12
hours of pain relief. The “MS” stands for the salt name, morphine
sulphate. Morphine is generally available. There are immediate-release dosage forms of oxycodone and morphine in tablet,
capsule, and liquid form. Meperidine is available only in immediate-release dosage forms, both oral and injectable. The analgesic effects of immediate-release dosage forms of all three drugs
typically last for about 4 hours.
Opioids also suppress the medullary cough centre, which
results in cough suppression. The most commonly used opioid
for this purpose is codeine (see Chapter 37). Hydrocodone is
also used in many cough suppressants, either alone or in combination with other drugs. Sometimes opioid-related cough
suppressants have a depressant effect on the CNS and cause
sedation. To avoid this problem, dextromethorphan, a nonopioid cough suppressant, is often given instead (see Chapter 37).
Constipation from decreased gastrointestinal (GI) motility is often an unwanted adverse effect of opioids resulting
from their anticholinergic effects. However, these effects
are sometimes helpful in treating diarrhea. Some of the
opioid-containing antidiarrheal preparations are opium/
belladona tincture (paregoric) and diphenoxylate/atropine
(Immodium®) tablets.
Contraindications
Contraindications to the use of opioid analgesics include
known drug allergy and severe asthma. It is not uncommon for
patients to state they are allergic to codeine, when, in most of
these patients, nausea was the “allergic” reaction. Many patients
CHAPTER 11 Analgesic Drugs
Opioid-Induced Adverse Effects
by Body System
TABLE 11.7
Body System
Adverse Effect
Central nervous
Sedation, disorientation, euphoria, lightheadedness, dysphoria, lowered seizure threshold,
tremors
Hypotension, palpitations, flushing
Respiratory depression and asthma exacerbation
Nausea, vomiting, constipation, biliary tract spasm
Urinary retention
Itching, rash, wheal formation
Cardiovascular
Respiratory
Gastrointestinal
Genitourinary
Integumentary
will claim to be allergic to morphine because it causes itching.
Itching is a pharmacological effect due to histamine release and
not an allergic reaction. Thus, it is important to determine the
exact nature of a patient’s stated allergy. Although not absolute
contraindications, extreme caution is to be used in cases of
respiratory insufficiency, especially when resuscitative equipment is not available; conditions involving elevated intracranial
pressure (e.g., severe head trauma); morbid obesity or sleep
apnea; myasthenia gravis; paralytic ileus (bowel paralysis); and
pregnancy, especially with long-term use or high doses.
Adverse Effects
Many of the unwanted effects of opioid analgesics result from
their pharmacological effects in areas other than the CNS. Some
of these unwanted effects can be explained by the drug’s selectivity for the receptors listed in Table 11.6. The various body
systems that the opioids affect, and the corresponding adverse
effects, are summarized in Table 11.7.
Opioids that have an affinity for µ receptors, and that have
rapid onset of action, produce marked euphoria. These are the
opioids that are most likely to be misused and used recreationally by the lay public as well as by health care providers, who
often have relatively easy access. The person taking opioids to
deliberately achieve an altered mental status will soon become
psychologically dependent (addicted; see Chapter 18).
In addition, opioids cause histamine release. It is thought
that this histamine release is responsible for many of the drugs’
unwanted adverse effects, such as itching or pruritus, rash, and
hemodynamic changes. Histamine release causes peripheral
arteries and veins to dilate, which leads to flushing and orthostatic hypotension. The amount of histamine release that an opioid analgesic causes is a result of its chemical class. The naturally
occurring opiates (e.g., morphine) elicit the most histamine
release; the synthetic opioids (e.g., meperidine) elicit the least
histamine release. (See Table 11.5 for a list of the opioids and
their respective chemical classes.)
The most serious adverse effect of opioid use is CNS depression, which may lead to respiratory depression. When death
occurs from opioid overdose, it is almost always due to respiratory depression. When opioids are given, care must be taken
to titrate the dose so that the patient’s pain is controlled without
175
affecting respiratory function. Individual responses to opioids
vary, and patients may occasionally experience respiratory compromise despite careful dose titration. Respiratory depression
can be prevented in part by using drugs with short duration of
action and no active metabolites. Respiratory depression seems
to be more common in patients with a pre-existing condition causing respiratory compromise, such as asthma, chronic
obstructive pulmonary disease, or sleep apnea. Respiratory
depression is also dependent on the degree of sedation (see
Toxicity and Management of Overdose, below).
GI tract adverse effects are common in patients receiving
opioids due to stimulation of GI opioid receptors. Nausea,
vomiting, and constipation are the most common adverse
effects. Opioids can irritate the GI tract, stimulating the chemoreceptor trigger zone in the CNS, which, in turn, may cause
nausea and vomiting. Opioids slow peristalsis and increase
water absorption from intestinal contents. These two actions
combine to produce constipation. This problem is more pronounced in hospitalized patients who are nonambulatory.
Patients may require laxatives (see Chapter 40) to help maintain normal bowel movements.
Urinary retention, or the inability to void, is another
unwanted adverse effect of opioid analgesics caused by increasing the sphincter tone of the bladder by sympathetic overstimulation, resulting in increased bladder outlet resistance. Opioids
also decrease the sensation of bladder fullness by partially
inhibiting the parasympathetic nerves that innervate the bladder. This is sometimes prevented by giving low dosages of an
opioid agonist–antagonist, an opioid antagonist, or a cholinergic agonist (see Chapter 21) such as bethanechol.
Severe hypersensitivity or anaphylactic reaction to opioid
analgesics is rare. Many patients will experience GI discomforts or histamine-mediated reactions to opioids and call these
“allergic reactions.” However, true anaphylaxis is rare, even with
intravenously administered opioids. Some patients may report
flushing, itching, or wheal formation at the injection site, but
this is usually local and histamine mediated and not a true
allergy. Refer to Table 11.4 for additional information on opioid
adverse effects and their management.
Toxicity and Management of Overdose
Naloxone and naltrexone are opioid antagonists that bind
to and occupy all of the receptor sites (µ, κ, and δ). They are
competitive antagonists with a strong affinity for these binding
sites. Through such binding, they can reverse the adverse effects
induced by the opioid drug, such as respiratory depression.
These drugs are used in the management of opioid overdose and
less commonly for opioid addiction. The commonly used opioid
antagonists (reversal drugs) are listed in Table 11.8.
When treating an opioid overdose or toxicity, the symptoms
of withdrawal need to be considered. However, regardless of
potential withdrawal symptoms, when a patient experiences
severe respiratory depression, naloxone must be given. In
Canada, take-home naloxone kits are available in most pharmacies and walk-in clinics and come with information about
176
PART 2 Drugs Affecting the Central Nervous System
TABLE 11.8
Opioid Antagonists (Reversal
Generic Name
Trade Name
Drugs)
naloxone hydrochloride Naloxone hydrochloride
(IV)
injection
naltrexone (PO)
ReVia
Cautions
Raised or lowered blood
pressure, dysrhythmias, pulmonary
edema, withdrawal
Nervousness, headache,
nausea, vomiting,
pulmonary edema,
withdrawal
signs of overdose (e.g., altered mobility and speech, altered consciousness including confusion/drowsiness, respiratory depression, constricted pupils), as well as how to administer the drug
as a nasal spray or injectable (Health Canada, 2019a). If you
suspect an overdose, it is important to stay with the patient
or person, call for assistance or 911 if in the community, and
administer naloxone. Naloxone kits have been used by first
responders (paramedics and firefighters) to successfully reverse
thousands of overdoses in Canada. Since take-home kits were
made available in the community, this number has continued
to increase.
Some degree of physical dependence is expected in opioidtolerant patients. The extent of opioid tolerance is most visible when an opioid drug is discontinued abruptly or when an
opioid antagonist is administered. This situation usually leads
to symptoms of opioid withdrawal, also known as abstinence
syndrome (see Chapter 18). This condition can occur after as
little as two weeks of opioid therapy in patients who are opioid naive. Gradual dosage reduction after chronic opioid use,
when possible, helps to minimize the risk and severity of withdrawal symptoms.
Respiratory depression is the most serious adverse effect
associated with opioids. Stimulating the patient may be adequate
to reverse mild hypoventilation. If this is unsuccessful, ventilatory assistance using a bag and mask or endotracheal intubation may be needed to support respiration. Administration
of opioid antagonists (e.g., naloxone) may also be necessary to
reverse severe respiratory depression. Careful titration of dose
until the patient begins to breathe independently will prevent
over-reversal. The effects of naloxone are short lived, usually
lasting about one hour. With long-acting opioids, respiratory
depressant effects may reappear, and naloxone may need to be
re-dosed.
The onset of withdrawal symptoms is a direct result of the
half-life of the opioid analgesic being used. Withdrawal symptoms resulting from discontinuing or the reversal of therapy
with short-acting opioids (codeine, hydrocodone bitartrate,
morphine, and hydromorphone) will appear within 6 to 12
hours and peak at 24 to 72 hours. Withdrawal symptoms usually
subside within 7 to 10 days but depend on a variety of factors
(e.g., amount taken, length of time taking the drug, severity of
Administration of Naloxone Take-Home Kit
Naloxone 0.4 mg/mL IM
Naloxone 4 mg Nasal Spray
Place person into recovery
position and initiate rescue
breathing if required.
Place person in supine position
and support the neck and
initiate rescue breathing if
required.
Check expiry date on
packaging
Check expiry date on
packaging
Remove top from glass vial
or remove cap from vial,
depending on what is supplied in the kit.
After removing the cap, be
sure to clean the top of the
vial with an alcohol swab.
Using syringe supplied, draw
up entire 1 mL vial and
remove all excess air from
syringe.
Landmark using rectus femoris or vastus lateralis site.
Clean landmarked area with
alcohol swab and inject contents of the syringe into the
muscle tissue at 90° angle.
Note: Most take-home kits suggest exposing thigh as much
as possible, divide quadriceps
muscle into thirds and inject
all contents of the syringe into
middle section at 90° angle.
If not already in recovery
position, put person into
recovery position and
continue rescue breathing
if required.
It can take up to 2 to 5 minutes for naloxone to take
effect. Repeat injection after 2 minutes if no change
is observed or when help
arrives.
Take nasal spray from
packaging and hold the
device.
Position spray into right or left
nares and push all contents
of spray into the nares.
Place person into recovery
position and continue rescue breathing if required.
Repeat spray (with new
package) every 5 minutes
if person does not become
conscious or continues to
show signs of respiratory
depression, and/or when
help arrives.
dependence). Withdrawal symptoms associated with the long
half-life drugs (methadone and transdermal fentanyl) may not
appear for 24 hours or more after drug discontinuation and may
be milder.
Interactions
Potential drug interactions with opioids are significant.
Coadministration of opioids with alcohol, antihistamines, barbiturates, benzodiazepines, promethazine, and
other CNS depressants can result in additive respiratory
depressant effects. The combined use of opioids (such as
CHAPTER 11 Analgesic Drugs
177
meperidine) with monoamine oxidase inhibitors, such as
selegiline, can result in respiratory depression, seizures,
and hypotension.
Other abnormal results include a decrease in urinary 17-ketosteroid levels and an increase in urinary alkaloid and glucose
concentrations.
Laboratory Test Interactions
Dosages
Opioids can cause an abnormal increase in the serum levels
of amylase, alanine aminotransferase, alkaline phosphatase,
bilirubin, lipase, creatinine kinase, and lactate dehydrogenase
(see Lab Values Related to Drug Therapy: Analgesics box).
For the recommended initial dosages of selected analgesic drugs
in opioid-naive patients, see the Dosages table on p. 181. Drug
pharmacokinetics for selected drugs are provided in the Drug
Profiles box.
LAB VALUES RELATED TO DRUG THERAPY
Analgesics
Laboratory Test
Normal Ranges Rationale for Assessment
Alkaline phosphatase 30–120 units/L
(ALP)
Alanine aminotransferase (ALT)
4–36 units/L
Older adults may
have slightly
higher levels
than adults
Gamma-glutamyl
transferase (GGT)
Males/females 45
years of age
and older: 8–38
units/L
ALP is found in many tissues but
is found in highest concentrations in the liver, biliary tract,
and bone. Detection of this
enzyme is important for determining liver and bone disorders. Enzyme levels of ALP are
increased in both extrahepatic
and intrahepatic obstructive
biliary disease and cirrhosis or
other liver abnormalities.
ALT is found mainly in the liver
and, in lesser amounts, in the
kidneys, heart, and skeletal
muscle. If there is injury or disease to the liver parenchyma
(cells), it will cause a release
of this liver cellular enzyme
into the bloodstream and thus
elevate serum ALT levels. Most
ALT elevations are from liver
disease. Therefore, if medications are then metabolized by
the liver, this metabolic process
will be altered and possibly
lead to toxic levels of drugs.
GGT is an enzyme that is present
in liver tissue; when there
is damage to the liver cells
(hepatocytes) that manufacture bile, the enzyme will
be released throughout the
cell membranes and into the
blood. The normal values for
individuals of African ancestry
are double those of individuals
who are White.
Laboratory Test
Normal Ranges Rationale for Assessment
Aspartate aminotransferase (AST)
0–35 units/L
Lactic dehydrogenase (LDH)
100–190 units/L
AST is elevated with hepatocellular diseases. With disease
or injury of liver cells, the cells
lyse and the AST is released
and picked up by the blood; the
elevation of AST is a result of
the number of cells affected by
disease or injury.
LDH is found in cells of many body
tissues including the heart,
liver, red blood cells, kidneys,
skeletal muscles, brain, and
lungs. Because it is in so many
tissues, the total LDH level is
not a specific indicator of one
disease. If there is disease or
injury affecting cells containing
LDH, the cells lyse and LDH is
released from the cells into the
bloodstream, thus increasing
LDH levels. This enzyme is
just part of the total picture of
altered liver function which, if
present, will then decrease the
breakdown and metabolism of
drugs and other chemical compounds, resulting in elevated
blood levels of drugs.
Note: Usually levels that are 3 to 5 times the upper level of the normal range of the enzyme test are considered significant and are indicative of
liver tissue damage. As well, elevation of a single test may not be clinically significant for liver damage.
178
PART 2 Drugs Affecting the Central Nervous System
DRUG PROFILES
Opioid Agonists
morphine sulphate
Morphine sulphate, a naturally occurring alkaloid derived
from the opium poppy, is the drug prototype for all opioid
drugs. It is classified as a Schedule I controlled substance.
Morphine is indicated for severe pain and has a high abuse
potential. It is available in oral, injectable, and rectal dosage
forms. Extended-release forms include MS Contin, M-Eslon®,
Kadian®, and Avinza®. Morphine also has a potentially toxic
metabolite known as morphine-6-glucuronide. Accumulation
of this metabolite is more likely to occur in patients with kidney impairment. For this reason, other Schedule I opioids
such as hydromorphone (Dilaudid®) and fentanyl (see fentanyl drug profile) may be safer analgesic choices for patients
with kidney insufficiency. Drug profile information for hydromorphone is similar to that for morphine and meperidine.
However, it is essential that all health care providers realize
that hydromorphone is about five to eight times more potent
than morphine. One milligram of IV, IM, or subcut hydromorphone hydrochloride is equivalent to 7 mg of IV, IM, or subcut morphine. Often, this difference in potency is not taken
into account when prescribing, and deaths have been reported
when larger doses of hydromorphone are given. Epidural dosage forms are injected onto the dura mater of the spinal cord.
Epidural analgesics have the potential for causing increased
intracranial pressure, especially with multiple injections, and
increased CNS depression when given with other CNS depressant drugs. Other CNS depressant drugs are not to be given
without orders from an anaesthesiologist.
PHARMACOKINETICS
Onset of
Route Action
Peak Plasma
Elimination Duration
Concentration Half-Life
of Action
IM
30–60 min
Rapid
1.7–4.5 hr
6–7 hr
codeine sulphate/phosphate
Codeine sulphate (oral) (codeine phosphate as injection) is
a natural opiate alkaloid (Schedule I) obtained from opium.
It is similar to morphine sulphate in terms of its pharmacokinetic and pharmacodynamic properties. In fact, about 10% of a
codeine dose is metabolized to morphine in the body. However,
codeine is less effective as an analgesic and is the only agonist to
possess a ceiling effect (meaning that increasing the dose beyond
a certain point will not increase the response). Therefore, it is
more commonly used as an antitussive drug in an array of cough
preparations (see Chapter 37). Codeine combined with acetaminophen (tablets or elixir) is classified as a Schedule I controlled substance and is commonly used for control of mild to
moderate pain as well as cough. Codeine causes GI tract upset,
and many patients will say they are allergic to codeine, when in
fact it just upsets their stomach. Codeine is metabolized in the
liver and converted to morphine through the enzyme CYP2D6.
Some individuals have a genetic polymorphism to this enzyme,
preventing them from metabolizing it appropriately. There has
been a growing concern for individuals who are so-called “ultrarapid metabolizers” as they convert codeine into morphine more
rapidly, leading to dose-related opioid adverse effects. Current
practice regarding codeine administration in pediatrics has been
linked to serious morbidity and mortality. Two deaths and one
resuscitation of North American children who were prescribed
appropriate age–weight doses of codeine have occurred. These
events prompted Health Canada to issue a recommendation that
codeine and codeine-containing products are not to be used in
children under the age of 18 (Health Canada, 2019b).
PHARMACOKINETICS
Onset of
Route Action
Peak Plasma
Concentration
Elimination
Half-Life
Duration
of Action
PO
35–45 min
2.5–4 hr
4–6 hr
15–30 min
fentanyl
Fentanyl is a synthetic opioid (Schedule I) used to treat moderate to severe pain. Like other opioids, it also has a high misuse or abuse potential. It is available as a parenteral injection,
transdermal patch, and sublingual tablet. The injectable form of
fentanyl is used most commonly in perioperative settings and
in Critical Care Unit settings for sedation during mechanical
ventilation. The parenteral form can be used subcutaneously or
sublingually, depending on the patient’s ability to manage sublingual administration. If administered sublingually, the drug
must remain there for at least 5 minutes. Oral bioavailability of
fentanyl is negligible and therefore this medication cannot be
taken orally. Patients are generally unable to keep more than 1.5
mL to 2 mL under the tongue before it dribbles into the mouth,
rendering it inactive. The sublingual and transdermal forms
are used primarily for long-term control of both malignant
and nonmalignant persistent pain. Fentanyl is a potent analgesic. Fentanyl at a dose of 0.1 mg given intravenously is roughly
equivalent to 10 mg of morphine given intravenously.
The transdermal delivery system (patch) has been shown to
be highly effective in the treatment of various persistent pain
syndromes such as cancer-induced pain, especially in patients
who cannot tolerate oral medications. This route is not to be
used in opiate-naive patients or for acute pain relief. Fentanyl
patches are difficult to titrate and are best used for nonescalating
pain. Second, if the opioid is not morphine, convert its dose to
the equianalgesic dose of morphine. Finally, calculate the equipotent transdermal fentanyl dosage. These tables are conservative in their dosages for achieving pain relief, and supplemental
short-acting opioid analgesics should be added as needed.
Fentanyl patches take 6 to 12 hours to reach steady-state
pain control after the first patch is applied, and supplemental
short-acting therapy may be required. Most patients will experience adequate pain control for 72 hours with this method of
fentanyl delivery. A new patch is to be applied every 72 hours. It
is important to remove the old patch when applying a new one.
It takes about 20 hours for fentanyl to reduce by 50% once the
patch is removed.
Health Canada has issued many safety warnings about
the use of fentanyl patches. Fentanyl patches are intended for
179
CHAPTER 11 Analgesic Drugs
management of persistent or cancer pain in opioid-tolerant
patients whose pain is not adequately controlled by other types of
medications. These patches are not recommended for acute pain
situations such as postoperative pain. Deaths have occurred from
drug-induced respiratory arrest when these conditions have not
been met. Patients who are considered opioid tolerant are those
who have been taking at least 60 mg of oral morphine daily or
at least 30 mg of oral oxycodone daily or at least 8 mg of oral
hydromorphone daily or an equianalgesic dose of another opioid. Other hazards associated with the use of fentanyl patches are
cutting the patch and exposing the patch to heat (e.g., via a heating pad or sauna), both of which accelerate the diffusion of the
drug into the patient’s body. Fentanyl patches should not be cut
for use. In the agency setting, fold used patches in half and place
in the needle disposal container, or place in a tamperproof container and return to a community pharmacy, to prevent misuse.
PHARMACOKINETICS
Route
Onset of Peak Plasma Elimination Duration
Action Concentration Half-Life
of Action
IV
Rapid
Minutes
1.5–6 hr
30–60 min
Transdermal 12–24 hr
48–72 hr
Delayed
1–2 hr
IM
20–30 min
1.5–6 hr
13–40 hr
7–15 min
meperidine hydrochloride
Meperidine hydrochloride (Demerol®) is a synthetic opioid
analgesic (Schedule I). Meperidine must be used with caution,
if at all, in older adults and in patients who require long-term
analgesia or who have kidney dysfunction. Meperidine has poor
oral bioavailability, variable IM absorption, and a short half-life
of 3 to 4 hours. An active metabolite, normeperidine, can accumulate to toxic levels and predispose patients to normeperidine
neurotoxicity, which does not respond to naloxone and makes
meperidine overdose particularly dangerous. Recognition of the
adverse consequences associated with meperidine use and its
overall unfavourable risk–benefit profile in all patient populations has resulted in a progressive movement away from meperidine use, and it has been removed from stock in many agencies.
It is not recommended for long-term pain treatment. However,
it may still be used for acute pain during postoperative periods,
as well as in emergency department settings for acute migraine
headaches. Meperidine is available in tablet and injectable form.
Although an oral tablet form is still available from one pharmaceutical company in Canada, the Institute for Safe Medication
Practices (ISMP) Canada has recommended the removal of oral
meperidine from hospital formularies and is also establishing
safe practices surrounding the prescribing of parenteral meperidine, including the use of other, safer alternatives for analgesia.
PHARMACOKINETICS
Onset of Peak Plasma
Elimination Duration
Route Action
Concentration Half-Life
of Action
PO
15–20 min 1–2 hours
3–4 hours
3–5 hours
methadone hydrochloride
Methadone hydrochloride (Metadol®) is a synthetic opioid
analgesic (Schedule I). It is the opioid of choice for the detoxification treatment of persons addicted to opioids in methadone
maintenance programs. Use of agonist–antagonist opioids (e.g.,
pentazocine) in patients addicted to heroin or those in methadone-maintenance programs can induce significant withdrawal
symptoms. There has been renewed interest in the use of methadone for severe persistent (e.g., neuropathic) and cancer-related
pain that requires daily, continuous, long-term opioid treatment
that is opioid-responsive, and for which alternative options are
inadequate. Methadone dosing for pain is different from methadone dosing for opioid dependence because of tolerance to the
analgesic effects of opioids. The drug is readily absorbed through
the GI tract with peak plasma concentrations at 4 hours for single dosing. Methadone is unique in that its half-life of 24 to 36
hours is longer than its duration of activity because it is bound to
the tissues of the liver, kidneys, and brain. With repeated doses,
the drug accumulates in these tissues and is slowly released, thus
allowing for 24-hour dosing. Methadone is eliminated through
the liver, which makes it a safer choice than some other opioids
for patients with kidney impairment. There has been concern
recently that the prolonged half-life of the drug is a cause of
unintentional overdoses and deaths. There is also concern that
methadone may cause cardiac dysrhythmias. Methadone is
available for oral use in liquid form. In 2015, methadone could
only be prescribed by health care providers who received an
exemption pursuant to section 56 of the Controlled Drugs and
Substances Act from the Minister of Health (Canada). This regulatory restraint was removed from the Controlled Drugs and
Substances Act by the Government of Canada on May 19, 2018
(https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/exemptions/
methadone-program.html). As a result, health care providers
who have authority to prescribe are no longer required to obtain
an exemption and can prescribe methadone in certain cases: if
the client/animal is under their direct professional care, and if
methadone is required for the condition the client/animal is
being treated for.
PHARMACOKINETICS
Onset of Peak Plasma
Elimination
Route Action
Concentration Half-Life
PO
Rapid
1 hr
3.9–12.9 hr
Duration
of Action
24–72 hr
Note: The pharmacokinetics of methadone change with repeat
dosing (with continuous dosing, peak at 3-5 days, half life increases
up to 59 hours)
Opioid Agonist–Antagonists
Opioids with mixed actions are often called agonist–antagonists (Schedule I). They bind to the µ receptor and can therefore
compete with other substances for these sites. They either exert
no action (i.e., they are competitive antagonists) or have only
limited action (i.e., they are partial agonists). They are similar
to the opioid agonists in terms of their therapeutic indications;
180
PART 2 Drugs Affecting the Central Nervous System
however, they have a lower risk of misuse and addiction. The
antagonistic activity of this group can produce withdrawal
symptoms in opioid-dependent patients. Their use is contraindicated in patients who have shown hypersensitivity reactions
to the drugs.
These drugs have varying degrees of agonist and antagonist effects on the different opioid receptor subtypes. They
are used in situations requiring short-term pain control, such
as after obstetrical procedures. They are sometimes chosen
for patients who have a history of opioid addiction. These
medications can both help prevent overmedication and
reduce post-treatment addictive cravings in these patients.
Combination products of buprenorphine hydrochloride and
naloxone dehydrate offer physicians an in-office treatment
of addiction (see Chapter 18). These drugs are normally not
strong enough for management of longer-term persistent
pain (e.g., cancer pain, persistent lower back pain). They are
not to be given concurrently with full opioid agonists, because
they may both reduce analgesic effects and cause withdrawal
symptoms in opioid-tolerant patients. Adverse reactions are
similar to those with opioids but with a lower incidence of
respiratory depression. Four opioid agonist–antagonists
are currently available: a buprenorphine transdermal patch
(Butrans®), butorphanol tartrate, nalbuphine (Nubain®), and
pentazocine (Talwin®). They are available in various dosage forms as indicated in the dosage table. Buprenorphine
hydrochloride is also available in combination with the opioid antagonist naloxone (Suboxone) to enhance its opioid
antagonistic effect, which is usually weaker than the agonistic effects of the drug.
Opioid Antagonists
Opioid antagonists produce their antagonistic activity by competing with opioids for CNS receptor sites.
naloxone hydrochloride
Naloxone hydrochloride is a pure opioid antagonist. It has no
agonist morphine-like properties and works as a blocking drug
to the opioid drugs. Accordingly, the drug does not produce analgesia or respiratory depression. Naloxone is the drug of choice
for the complete or partial reversal of opioid-induced respiratory
depression. It is also indicated in cases of suspected acute opioid
overdose. Failure of the drug to significantly reverse the effects of
the presumed opioid overdose indicates that the condition may
not be a result of an opioid overdose. The primary adverse effect
is opioid withdrawal syndrome, which can occur with abrupt
over-reversal in opioid-tolerant patients. Naloxone is available in
injectable and nasal spray form. Use of the drug is contraindicated in patients with a history of hypersensitivity to it.
PHARMACOKINETICS
Onset of Peak Plasma Elimination Duration
Route Action
Concentration Half-Life
of Action
IV
<2 min
Rapid
64 min
Variable depending on dose
and route
naltrexone hydrochloride
Naltrexone hydrochloride (ReVia®) is an opioid antagonist used
as an adjunct for the maintenance of an opioid-free state in former opioid addicts. It has been recognized as a safe and effective adjunct to psychosocial treatments of alcoholism. It is also
indicated for reversal of postoperative opioid-induced respiratory depression. Nausea and tachycardia are the most common
adverse effects resulting from a reversal of the opioid effect.
Use of naltrexone hydrochloride is contraindicated in cases of
known drug allergy and in patients with hepatitis or liver dysfunction or failure.
PHARMACOKINETICS
Onset of Peak Plasma Elimination Duration
Route Action
Concentration Half-Life
of Action
PO
30–60 min
1.5–2 hr
25 hr
24–48 hr
oxycodone hydrochloride
Oxycodone hydrochloride is an analgesic drug that is structurally similar to morphine and has comparable analgesic activity
(Schedule I). It is also commonly combined in tablets with acetaminophen (Percocet®) and with aspirin (Ratio-Oxycodone®).
Oxycodone is also available in immediate-release formulations (Oxy IR) and sustained-release formulations (OxyNeo).
Oxycodone and naloxone (Targin®) is a new controlled-release
combination offering a dual therapeutic effect. It is indicated for
severe pain requiring daily, long-term opioid treatment, and the
naloxone blocks and reduces the adverse effects of opioid analgesic-induced constipation. Naloxone blocks the pain-relieving
effects of opioids in general, but this formulation of oral naloxone blocks only the bowel adverse effects and is not absorbed
through the intestine to block the drug’s pain-relieving properties in the body and brain. A somewhat weaker but commonly
used opioid is hydrocodone bitartrate (Schedule I), which is
available in a tablet and as a syrup. It is available in combination
with phenyltoloxamine (Tussinex®) as a controlled-release resin.
The addition of phenyltoloxamine potentiates the antitussive
effect of hydrocodone bitartrate.
PHARMACOKINETICS (IMMEDIATE RELEASE)
Onset of Peak Plasma Elimination Duration
Route Action
Concentration Half-Life
of Action
PO
10–15 min
1 hr
2–3 hr
3–6 hr
NONOPIOID AND MISCELLANEOUS
ANALGESICS
Acetaminophen (Tylenol) is the most widely used nonopioid
analgesic. Over 4 billion doses of acetaminophen are sold each
year in Canada, with approximately 15% of these sales for prescription products (Health Canada, 2015). Combination products (acetaminophen plus another medication) (see Table 11.9
for a common example of combination products including acetaminophen, codeine, and caffeine), including over-the-counter
CHAPTER 11 Analgesic Drugs
181
Dosages
Selected Analgesic Drugs and Related Drugs
Drug
Pharmacological Class
Usual Dosage Range
Indications
Opioids
codeine sulphate (oral);
codeine phosphate injection
Opioid; opiate; opium alkaloid
Adults/Children (18 yr and older)
PO: 15–60 mg q4–6 hr
IV: 30–60 mg q4–6 hr
Analgesia
Adults/Children (18 yr and older)
15–60 mg tid–qid; maximum 120 mg/day
Antitussive
fentanyl (Abstral®, Duragesic
Mat, Fentanyl Citrate
Injection®)
Opioid analgesic
All doses titrated to response, starting with lowest
Procedural sedation or adjunct to
effective dose
general anaesthesia
Children (2–12 yr)
IV: 2–3 mcg/kg/dose
Adults
IV: 2–150 mcg/kg (range from minor to complicated procedures)
Adults
Relief of moderate to severe acute
Epidural: 100 mcg diluted in 8 mL 0.9% sodium chloride
pain; relief of persistent pain,
on demand; continuous infusion 1 mcg/kg/hr
including cancer pain
Duragesic (transdermal patch): 12–100 mcg/h q72 hr
Buccal/Sublingual tablets (Fentora): Begin with lowest
dosage 100 mcg and titrate as necessary
meperidine hydrochloride
(Demerol)
Opioid analgesic
Children
Meperidine hydrochloride use not
recommended because of the
IM/subcut: 1.1–1.8 mg/kg q2–3 hr prn (max 100 mg/dose)
unpredictable effects of
IM/subcut: 1.1–1.2 mg/kg 30–90 min before anaesthesia
neurometabolites at analgesic
Adults
doses and potential for seizures;
PO (18 yr and older): 50–150 mg q3–4 hr prn
use for 2 days
IM/subcut: 50–100 mg 30–90 min before
anaesthesia; 50–150 mg q3 hr prn for pain
Obstetric analgesia; preoperative
sedation
methadone hydrochloride
(Methadose®, Metadol®,
Metadose®) (D)
Opioid analgesic
Adults
Opioid analgesic, relief of persistent
pain, opioid detoxification, opioid
PO for pain 2.5–10 mg q4 hr × 3–5 days; followed by fixed
addiction maintenance
dose q8–12 hr depending on patient needs
morphine sulphate (M.O.S.
Sulphate®, MS IR®,
Statex®) morphine
hydrochloride (Doloral
syrup®)
Opioid; opiate; opium alkaloid
Children
PO: 0.1–0.5 mg/kg/dose q3–4 hr subcut: 0.1–0.2
mg/kg q4 hr (maximum 15 mg/single dose)
Adults
PO: 10–30 mg q4 hr
IV/IM/subcut: 2.5–15 mg q2–4 hr
Opioid analgesia
morphine sulphate,
continuous release
(Kadian, M-ESLON,
MS Contin)
Opiate analgesic; opium
alkaloid
Adults only
Relief of moderate to severe pain
oxycodone hydrochloride,
immediate-release
(Oxy-IR®)
Opioid, synthetic
Children
PO: 1.25–2.5 mg q6 hr prn
Adults
PO: 5–20 mg q4–6 hr prn
Relief of moderate to severe pain
oxycodone hydrochloride,
continuous-release (ACT
Oxycodone SR®, OxyNeo)
Opioid, synthetic
Adults only
PO: 10–20 mg q12 hr, titrated to relief
Relief of moderate to severe pain
Opioid antagonist
Neonates
IM/IV/subcut: 0.1 mg/kg at 2–3-min intervals
Children
IV: 0.01 mg/kg IV followed by 0.1 mg/kg if needed;
0.005–0.01 mg/kg; repeat in 2–3-min intervals
Adults
IV: 0.4–2 mg; repeat in 2–3 min if needed;
0.1–0.2 mg; repeat in 2–3-min intervals
Opioid-induced depression
Opioid Antagonists
naloxone hydrochloride
Opioid analgesia
PO: 10–100 mg q8 hr to 100 mg q12 hr daily
Treatment of opioid overdose;
postoperative anaesthesia reversal
Treatment of opioid overdose;
postoperative anaesthesia reversal
182
PART 2 Drugs Affecting the Central Nervous System
Dosages—cont’d
Selected Analgesic Drugs and Related Drugs
Drug
Pharmacological Class
naltrexone hydrochloride (ReVia) Opioid antagonist
Nonopioids
acetaminophen (Tylenol®,
others)
Nonopioid analgesic,
antipyretic
tramadol hydrochloride
Nonopioid analgesic
immediate-release
(with opioidlike activity)
(Apo-Tramadol®) tramadol
hydrochloride extended-release
(Durela®, Ralivia®, Tridura®)
Usual Dosage Range
Indications
Adults
PO: 50 mg daily or 100 mg every other day
PO: 50–100 mg q3–4 hr
Maintenance of opioid-free state
Children
PO/PR: 15mg/kg/dose Q4-6 hours PRN (with maximum 5
doses per day or 75mg/kg or 4g daily)
Adults
PO/PR: 325–650 mg q4–6 hr; do not exceed 4 g/day
In those with alcohol disorders, do not exceed 2 g/day
Relief of mild to moderate pain
Adults 18 yr and older
PO: 50–100 q4–6 hr; not to exceed 400 mg/day
PO: 100–300 mg q24 hr; not to exceed 300 mg/day
Relief of moderate to moderately
severe pain
Relief of mild to moderate pain
IM, Intramuscular; IV, intravenous; PO, oral; subcut, subcutaneous
Acetaminophen–Codeine
Tablet Combinations
TABLE 11.9
Combination
Tylenol with
codeine no-1
TAB®
Tylenol with
codeine no-2
TAB®
Tylenol with
codeine no-3
TAB®
Tylenol with
codeine no-4
TAB®
Amount of
Amount of Amount of
Acetaminophen* Codeine
Caffeine
300 mg
8 mg
15 mg
300 mg
15 mg
15 mg
300 mg
30 mg
15 mg
300 mg
60 mg
None
*Depending on the pharmaceutical company, there are some variations in the amount of acetaminophen.
(OTC) cough and cold remedies and pain relievers containing
opioids, make up more than half of all acetaminophen doses
sold (Health Canada, 2015).
All drugs in the NSAID class (which includes aspirin; ibuprofen; naproxen; the cyclo-oxygenase-2 [COX-2] inhibitor, celecoxib [Celebrex®]; and others) are nonopioid analgesics. These
drugs are discussed in greater detail in Chapter 49. They are used
for management of pain, especially pain associated with inflammatory conditions such as arthritis, because they have significant
anti-inflammatory effects in addition to their analgesic effects.
Miscellaneous analgesics include tramadol and transdermal
lidocaine and are discussed in depth in their respective drug profiles
in this chapter. Capsaicin is a topical product made from several different types of peppers. It works by decreasing or interfering with
substance P, a pain signal in the brain. Capsaicin is available over the
counter. It can be used for muscle pain, joint pain, and nerve pain.
Mechanism of Action and Drug Effects
The mechanism of action of acetaminophen is similar to that of
the salicylates. It blocks peripheral pain impulses by inhibition
of prostaglandin synthesis. Acetaminophen also lowers febrile
body temperature by acting on the hypothalamus, the structure
in the brain that regulates body temperature. Heat is dissipated
through resulting vasodilation and increased peripheral blood
flow. In contrast to NSAIDs, acetaminophen lacks anti-inflammatory effects (although there is some controversy in this area).
Although acetaminophen shares the analgesic and antipyretic
effects of the salicylates and other NSAIDs, it does not have
many of the unwanted effects of these drugs. For example, acetaminophen products are not usually associated with cardiovascular effects (e.g., edema) or platelet effects (e.g., bleeding), as
aspirin and other NSAIDs are. They also do not cause the aspirin-related GI tract irritation or bleeding, nor any of the aspirin-related acid–base changes.
Indications
Acetaminophen is indicated for the treatment of mild to
moderate pain and fever. It is an appropriate substitute for
aspirin because of its analgesic and antipyretic properties.
Acetaminophen is a valuable alternative for those patients who
cannot tolerate aspirin or for whom aspirin may be contraindicated. Acetaminophen is also the antipyretic (antifever) drug of
choice in children and adolescents with flu syndromes because
the use of aspirin in such populations is associated with a condition known as Reye’s syndrome—a rare yet extremely serious
condition that causes swelling in the brain and liver (Chapman
& Arnold, 2019).
Contraindications
Contraindications to acetaminophen use include known drug
allergy, severe liver disease, and the genetic disease known as
glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.
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CHAPTER 11 Analgesic Drugs
Adverse Effects
Acetaminophen is an effective and relatively safe drug. It is
therefore available over the counter and in many combination
prescription drugs. Acetaminophen is generally well tolerated.
Possible adverse effects include rash, nausea, and vomiting.
Much less common but more severe are the adverse effects of
blood disorders or dyscrasias (e.g., anemias) and kidney function when acetaminophen is taken with light-to-moderate alcohol intake, and, of most concern, hepatotoxicity.
Toxicity and Management of Overdose
Most people do not realize that acetaminophen, despite its
OTC status, is a potentially lethal drug when taken in overdose.
Patients who are depressed (especially adolescents) may intentionally take an overdose of the drug without realizing the grave
danger involved.
The ingestion of large amounts of acetaminophen, as in
an acute overdose or even persistent unintentional misuse,
can cause liver necrosis. This is the most serious acute toxic
effect. Acute ingestion of acetaminophen doses of 150 mg/
kg (approximately 7 to 10 grams) or more may result in liver
toxicity. Acute hepatotoxicity can usually be reversed with
acetylcysteine, whereas long-term toxicity is more likely to
be permanent.
The standard maximum daily dose of acetaminophen for
healthy adults is 4 000 mg. At the time of writing this book,
Health Canada is considering additional steps to minimize the
risk of liver damage and improve acetaminophen safety—for
example, reducing the maximum daily recommended dose for
all oral and rectal forms of acetaminophen-containing products, decreasing the unit dose for some products, or both. As
well, product labelling and packaging, such as requiring children’s liquid products to be sold with an accurate dosing device
in the package, are also being considered.
Limitation of acetaminophen dosages to 2 000 mg or less
maximum daily dose may be necessary for patients with
risk factors such as advanced age or those with liver dysfunction. Excessive dosing may occur inadvertently with
the use of combination products that include a fixed ratio
of an opioid drug plus acetaminophen (e.g., hydrocodone
plus acetaminophen). Health care providers must be mindful of recommended daily dose limits when prescribing these
medications.
The long-term ingestion of large doses of acetaminophen
is more likely to result in severe hepatotoxicity, which may be
irreversible. Because the reported or estimated quantity of drug
ingested is often inaccurate and not a reliable guide to the therapeutic management of the overdose, serum acetaminophen
concentration should be determined no sooner than 4 hours
after the ingestion. If a serum acetaminophen level cannot be
determined, it should be assumed that the overdose is potentially toxic and treatment with acetylcysteine needs to be started.
Acetylcysteine is the recommended antidote for acetaminophen
toxicity and works by preventing the hepatotoxic metabolites of
acetaminophen from forming. It is most effective when given
within 10 hours of an overdose. Historically, the usual dosage
regimen—140 mg/kg oral loading dose, followed by 70 mg/kg
every 4 hours for 17 additional doses—is usually administered
intravenously according to protocol.
The oral drug is notoriously bad tasting, with an odour of
rotten eggs, and vomiting of an oral dose is common. It is recommended that the dose be repeated if vomiting occurs within
1 hour of dosing.
Interactions
A variety of substances may interact with acetaminophen.
Alcohol is potentially the most dangerous. Persistent heavy
alcohol abuse may increase the risk of liver toxicity from excessive acetaminophen use. For this reason, a maximum daily dose
of 2 000 mg is generally recommended. Health care providers
need to warn patients with regular intake of moderate to large
amounts of alcohol not to exceed recommended doses of acetaminophen because of the risk of liver dysfunction and possible
liver failure. Ideally, alcohol consumption is not to exceed the
recommended guidelines of 15 drinks per week for men and 10
drinks per week for women. Other drugs that can potentially
interact with acetaminophen include phenytoin, barbiturates,
warfarin sodium, isoniazid, rifampin, beta blockers, and anticholinergic drugs, all of which are discussed in greater detail
in later chapters. Drug pharmacokinetics for selected drugs are
provided in the Drug Profiles box.
DRUG PROFILES
acetaminophen
Acetaminophen (Tylenol) is an effective and relatively safe
nonopioid analgesic used for mild to moderate pain relief.
Acetaminophen is provided in oral and rectal dosage formulations. Acetaminophen is also a component of several prescription combination drug products, including with oxycodone
(Endocet®, Percocet).
PHARMACOKINETICS
Onset of Peak Plasma
Route Action
Concentration
Elimination Duration
Half-Life
of Action
PO
1–4 hr
10–30 min 0.5–2 hr
3–4 hr
tramadol hydrochloride
Tramadol hydrochloride (Ultram®) is categorized as a miscellaneous analgesic because of its unique properties. It is a
centrally acting analgesic with a dual mechanism of action.
It creates a weak bond to the µ (mu) opioid receptors and
inhibits the reuptake of both norepinephrine and serotonin.
Although it does have weak opioid receptor activity, tramadol is not currently classified as a controlled substance.
Tramadol is indicated for the treatment of moderate to
moderately severe pain. Tramadol is rapidly absorbed, and
its absorption is unaffected by food. It is metabolized in the
liver to an active metabolite (O-dimethyl tramadol) and
eliminated via renal excretion.
Tramadol has a relatively safe profile in comparison to other
opiates; however, two potential significant adverse effects of
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PART 2 Drugs Affecting the Central Nervous System
this drug are seizures and serotonin syndrome. Seizures have
been reported in patients taking tramadol and occur in patients
taking both normal and excessive dosages. Patients who may
be at risk are those receiving tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase
inhibitors, neuroleptics, or other drugs that reduce the seizure
threshold. There is also an increased risk of developing serotonin
syndrome when tramadol is taken concurrently with SSRIs (see
Chapter 17). Other adverse effects are similar to those of opioids
and include drowsiness, dizziness, headache, nausea, constipation, and respiratory depression.
Use of tramadol is contraindicated in cases of known drug
allergy, which may include allergy to opioids due to potential cross-reactivity. It is also contraindicated in cases of acute
intoxication with alcohol, hypnotics, centrally acting analgesics,
opioids, or psychotropic drugs. The drug is available only in
oral dosage forms, including a combination with acetaminophen (Tramacet®), as well as an extended-release formulation
(Durela, Ravilia, Zytram XL®). A new drug, tapentadol hydrochloride (Nucynta®) is structurally similar to tramadol, with a
dual mechanism of action. It is a µ (mu) agonist and a norepinephrine reuptake inhibitor. It is currently recommended to be
a scheduled opioid.
NURSING PROCESS
PHARMACOKINETICS
Pain may be acute or persistent and occurs in patients in all
settings and across the lifespan, thus leading to much distress.
Patients experiencing pain pose many challenges to the nurse,
prescribers, and other health care providers involved in their
care. The challenge is that pain is a complex and multifaceted
problem that requires astute assessment skills with appropriate
interventions based on the individual, the specific type of pain,
related diseases, or health status.
Medical associations, health care organizations, governing bodies, and professional nursing organizations have been
involved in defining guidelines and outcomes of care regarding assessment and management of pain. For example, the
Canadian Guideline for Safe and Effective Use of Opioids
(http://nationalpaincentre.mcmaster.ca/opioid/) is a national,
evidence-informed guideline to help primary care providers
and specialists safely and effectively use opioids to treat patients
with persistent non-cancer pain. In addition, the WHO (www.
who.int/en) has developed standards related specifically to
cancer pain and guidelines for management of acute pain and
pain in children. Professional nursing organizations, such as
the Registered Nurses Association of Ontario, have also created best-practice guidelines and standards of care, including
pain assessment and management (see https://rnao.ca/bpg/
guidelines/assessment-and-management-pain).
Onset of Peak Plasma
Elimination Duration
Route Action
Concentration Half-Life
of Action
ASSESSMENT
PO
30 min
2 hr
5–8 hr
Unknown
lidocaine, transdermal
Transdermal lidocaine is a topical anaesthetic and cardiac antidysrhythmic (see Chapter 26 discussion) that is formulated
into a patch (EMLA®), which is placed onto painful areas of the
skin. It is indicated for the treatment of post-herpetic neuralgia, a painful skin condition that remains after a skin outbreak
of shingles. Shingles is caused by the herpes zoster virus, also
known as the varicella zoster virus, which causes chickenpox in
children. Lidocaine patches provide local pain relief, and up to
three patches may be placed on a large painful area. However,
the patches are not to be worn for longer than 12 hours a day
to avoid potential systemic drug toxicity (e.g., cardiac dysrhythmias). Because they act topically, there are minimal systemic
adverse effects. However, the skin at the site of treatment may
develop redness or edema, and unusual skin sensations may
occur. These reactions are usually mild and resolve within a few
minutes to hours. Patches are applied only to intact skin with no
blisters. They can be used either alone or as part of adjunctive
treatment with systemic therapies such as antidepressants (see
Chapter 17), opioids, or anticonvulsants (see Chapter 15). Used
patches must be disposed of securely because they may be dangerous to children or pets. Specific pharmacokinetic data are
not listed due to the continuous nature of dosing. Studies have
demonstrated that a patch can provide varying degrees of pain
relief for 4 to 12 hours.
Adequate analgesia requires a holistic, comprehensive, and
individualized patient assessment with specific attention to the
type, intensity, and characteristics of the pain and of the levels
of comfort. Comfort, in this situation, is defined as the extent of
physical and psychological ease that an individual experiences.
Perform a thorough health history, nursing assessment, and
medication history as soon as possible or upon the first encounter with the patient, including questions about the following: (1)
allergies to nonopioids, opioids, partial or mixed agonists, or
opioid antagonists (see previous pharmacological discussion for
examples of specific drugs); (2) potential drug–drug or drug–
food interactions; (3) presence of diseases or CNS depression;
(4) history of the use of alcohol, street drugs, or any illegal drug
or substance and history of substance abuse, with information
about the substance, dose, and frequency of use; (5) results of
laboratory tests ordered, such as levels of serum ALT, ALP, GGT,
5′-nucleotidase, and bilirubin (indicative of liver function), or
levels of blood urea nitrogen (BUN) and creatinine (reflective
of kidney function); abnormal liver or kidney function that may
require lower doses of analgesic to prevent toxicity or overdosage (see Lab Values Related to Drug Therapy box: Analgesics
on p. 177); (6) character and intensity of the pain, including
onset, location, and quality (e.g., stabbing/knifelike, throbbing,
dull ache, sharp, diffuse, localized, referred); actual rating of
the pain using a pain assessment scale (see later); and any precipitating, aggravating, or relieving factors; (7) duration of the
pain (acute versus persistent); and (8) types of pharmacological,
nonpharmacological, or adjunctive measures that have been
CHAPTER 11 Analgesic Drugs
implemented, with further explanation of the treatment’s duration of use and overall effectiveness.
To be thorough and effective, include in the assessment the
factors or variables that may impact an individual’s pain experience, such as physical factors (e.g., age, gender, pain threshold,
overall state of health, disease processes, pathologies) and emotional, spiritual, and cultural variables (e.g., reaction to pain;
pain tolerance; fear; anxiety; stressors; sleep patterns; societal
influences; family roles; phases of growth and development;
religious, racial, or ethnic beliefs or practices). Age-appropriate
assessment tools are recommended in assessing pain across the
lifespan (see later discussion). For pediatric and older adult
patients, nonverbal behaviour or cues and information from
family members or caregivers may be helpful in identifying
pain levels. In an older adult, physical or cognitive impairment
may affect reporting of pain; however, this does not mean that
the older adult patient is not experiencing pain—the patient’s
reporting may just be altered. Persistent pain and pain associated with cancer are both complex and multifactorial problems
requiring a holistic approach with attention to other patient
reports, such as a decrease in activities of daily living, insomnia,
depression, social withdrawal, anxiety, personality changes, and
quality of life issues.
Perform a system-focused nursing assessment with collection of both subjective and objective data as follows: neurological status (e.g., level of orientation and alertness, level of
sedation, sensory and motor abilities, reflexes); respiratory status (e.g., respiratory rate, rhythm, and depth; breath sounds); GI
status (e.g., presence of bowel sounds; bowel patterns; reports of
constipation, diarrhea, nausea, vomiting, or abdominal discomfort); genitourinary (GU) status (e.g., urinary output, any burning or discomfort on urination, urinary retention); and cardiac
status (e.g., pulse rate and rhythm, blood pressure, any problems
with dizziness or syncope). Assess and document vital signs,
including blood pressure, pulse rate, respirations, temperature, and level of pain (now considered the fifth vital sign). It is
important to pull from one’s knowledge base and remember that
during the acute pain response, stimulation of the sympathetic
nervous system may result in elevated values for vital signs, with
an increase in blood pressure (120/80 mm Hg or higher), pulse
rate (100 beats/min or higher), and respiratory rate and depth
(20 breaths/min or higher and shallow breathing).
A variety of pain assessment tools are available that may be
used to gather information about the fifth vital sign. One basic
assessment tool is the Numeric Pain Intensity Scale (0 to 10 pain
rating scale); patients are asked to rate their pain intensity by
picking the number that most closely represents their level of
pain. The Verbal Rating Scale, another pain assessment tool,
uses verbal descriptors for pain, including words such as mild,
moderate, severe, aching, agonizing, or discomfort. The FACES
Pain Rating Scale is helpful in assessing pain in patients of all
ages and educational levels because it relies on a series of faces
ranging from happy to sad to sad with tears. The patient is asked
to identify the face that best represents the pain being experienced at that moment. When the patient is in acute pain, when
pain intensity is a primary focus for assessment, or when the
need is to determine the efficacy of pain management intervention, the simple, one-dimensional scales (e.g., the Numeric Pain
185
Intensity Scale) work best. Older adult patients, especially those
with cognitive impairment, may need more time to respond to
the assessment tool and may also require large-print versions of
written tools.
There are other assessment tools that are multidimensional
scales and are more beneficial in assessing patients who experience persistent pain rather than acute pain. One example is
the Brief Pain Inventory assessment tool, which includes a body
map so that the patient can identify on the figure the exact area
where pain is felt. This tool also helps in obtaining information
about the impact of pain on functioning. Assess pain before,
during, and after the pain intervention, as well as the level of
pain during activity and at rest. The following sections provide
assessment information for specific drug classes.
Nonopioids
For patients taking nonopioid analgesics, focus the assessment
not only on general data as described earlier but also on the
specific drug being given. For example, in those patients taking
acetaminophen, begin the assessment determining whether the
patient has allergies, is pregnant, or is breastfeeding. As mentioned in the pharmacology section, acetaminophen is contraindicated in those with severe liver disease and in patients with
G6PD deficiency. Additionally, due to possible adverse effects of
blood disorders (anemias) or kidney or liver toxicity, cautious
use is necessary. See pharmacology discussion for more information about acute overdose and persistent unintentional misuse. Also assess for any other medications the patient is taking,
because of the risk of excessive doses when taking combination
products containing acetaminophen. Inadvertent overdosing is
a possible consequence of this situation. Other drug interactions
and concerns are addressed in the pharmacology discussion.
Once therapy has been initiated, closely monitor for persistent acetaminophen poisoning, looking for symptoms such
as rapid, weak pulse; dyspnea; and cold and clammy extremities.
Long-term daily use of acetaminophen may lead to increased
risk of permanent liver damage; therefore, frequently monitor
the results of liver function studies. Adults who ingest higher-than-recommended dosages may be at higher risk of liver
dysfunction as well as other adverse effects such as loss of appetite, jaundice, nausea, and vomiting. Children are also at high
risk of liver dysfunction if the recommended dosage ranges
are exceeded. With the use of NSAIDs (e.g., ibuprofen, aspirin, and COX-2 inhibitors), assess kidney and liver functioning and gather information about GI disorders such as ulcers
(see Chapter 49 for more information on anti-inflammatory
drugs). With aspirin, age is important; this drug is not to be
given to children and adolescent patients because of the risk of
Reye’s syndrome. Aspirin may also lead to bleeding and ulcers,
so ruling out conditions that represent contraindications and
cautions to its use before therapy begins is important to patient
safety. With tramadol, assessment of age is important because
this drug is not recommended for use in individuals 75 years of
age or older.
A miscellaneous nonopioid analgesic, lidocaine transdermal,
is another option for managing different types of pain. For lidocaine transdermal patches, understand that this transdermal
drug is indicated in those with postherpetic neuralgia, and thus
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PART 2 Drugs Affecting the Central Nervous System
assess the herpetic lesion(s) and surrounding skin. When these
patches are used, they must be kept away from children and
pets and are not to be prescribed for young, small, or debilitated
patients because they are at higher potential for toxicity. Liver
function also needs to be assessed and monitored.
Opioids
When opioid analgesics or any other CNS depressants are
prescribed, focus assessment on vital signs; allergies; respiratory disorders; respiratory function (rate, rhythm, depth, and
breath sounds); presence of head injury (which will mask signs
and symptoms of increasing intracranial pressure); neurological status, with attention to level of consciousness or alertness
and level of sedation; sensory and motor functioning; GI tract
functioning (bowel sounds and bowel patterns); and GU functioning (intake and output). In addition, all opioids may cause
spasms of the sphincter of Oddi. If kidney and liver function
studies are ordered, monitor results because the risk of toxicity
increases with diminished function of these organs.
An additional concern is any past or present history of
neurological disorders such as Alzheimer’s disease, dementia,
multiple sclerosis, myasthenia gravis, or cerebrovascular accident (stroke)—the use of opioids may alter symptoms of the
disorder or disease process, possibly masking symptoms or
worsening the clinical presentation when no actual pathological changes have occurred. In these situations, use of another
analgesic or pain protocol may be indicated. Attention to age
is also important because both older adults and young patients
are more sensitive to opioids, as to many other medications. In
fact, older or younger age may be a contraindication to opioid use, depending on the specific drug. See the earlier pharmacology discussion regarding cautions, contraindications,
and drug interactions. See Special Populations: Children and
Special Populations: Older Adults boxes for use of opioids in
both age groups.
SPECIAL POPULATIONS: CHILDREN
Opioid Use
• Assessment of children is challenging, and all types of behaviour that may
indicate pain, such as muscular rigidity, restlessness, agitation, screaming,
fear of moving, and withdrawn behaviour, must be carefully considered.
• Pain management is more difficult to determine in children; depending on
age, children are less able or unable to express themselves. Frequently, the
reason older children do not verbalize their pain is their fear of the treatment, such as injections. Compassionate and therapeutic communication
skills, as well as the use of alternate routes of administration, as ordered,
will help the nurse in these situations.
• The “ouch scale” or FACES scale is often used to determine the level of
pain in children (Fig. 11.4). This scale is used to obtain the child’s rating of
the intensity of pain from 0 to 5 by means of simple face diagrams, from a
happy face for level 0 (no pain) to a sad, tearful face for level 5 pain. Parents
and caregivers play an important role in pain management in the child and
in noting any crying or distress.
• Pain assessment is important in children because they are often undermedicated. Always thoroughly assess a child’s verbal and nonverbal behaviour,
and never underestimate the child’s reports. Remember that parents and
caregivers can play an important role in this assessment.
• The child’s baseline age, weight, and height are important to document
because drug calculations are often based on these variables. With children, check and double-check all mathematical calculations for accuracy to
avoid excessive dosages; this is especially true for opioids.
• Analgesics must be given before pain becomes severe, with oral dosage
forms used first, if appropriate.
• If suppositories are used, be careful to administer the exact dose and not to
split, halve, or divide an adult dose into a child’s dose—this may result in the
administration of an unknown amount of medication and possible overdose.
• When subcut, IM, and IV medications are used, the principle of nontraumatic
care in the delivery of nursing care must be followed. One method to ensure
nontraumatic care is the application of a mixture of local anaesthetics or
other prescribed substances to the injection site before the injection is given.
EMLA (lidocaine/prilocaine) is a topical cream that anaesthetizes the site of
the injection; if ordered, apply 1 to 2-1/2 hours prior to the injection.
• Distraction and creative imagery may be used for younger children such as
toddlers or preschool-aged children.
• Children should always be monitored closely for any unusual behaviour
while they are receiving opioids.
• The following signs and symptoms should be reported to the physician
immediately if they occur: CNS changes such as dizziness, lightheadedness, drowsiness, hallucinations, changes in level of consciousness, or
sluggish pupil reaction. Do not administer further medication until receiving
further orders from the physician.
• Always monitor and document vital signs before, during, and after the
administration of opioid analgesics. An opioid medication is usually withheld if a patient’s respiration rate is less than 10 breaths/min or if there
are any changes in the level of consciousness. Always follow protocol, and
never ignore a patient’s status.
• Smaller doses of opioids (with close and frequent monitoring) are indicated for children. Giving oral medications with meals or snacks will help
decrease GI tract distress.
SPECIAL POPULATIONS: OLDER ADULTS
Opioid Use
• Record the patient’s weight and height before the start of opioid treatment,
if appropriate.
• Monitor the patient carefully for any changes in vital signs, level of consciousness, central nervous system (CNS) depression, respiratory rate, as
well as any changes indicative of respiratory function. Report and document these changes.
• Many institutionalized or hospitalized older adult patients can be stoic
about pain; older adult patients may also have altered presentations of
common illnesses so that the pain experience manifests in a different way,
or they may simply be unable to state how they feel in a clear manner.
The older adult patient may also have complex pain needs such as both
persistent and acute pain. Each patient, regardless of age, has the right to
a thorough pain assessment and adequate and appropriate pain management. It is a myth that aging increases one’s pain threshold. The challenge
is that cognitive impairment and dementia are often major barriers to pain
assessment. Nevertheless, many older adult patients are still reliable in
their reporting of pain, even with moderate to severe cognitive impairment
(see Evidence in Practice: Student Nurses’ Misconceptions of Adults with
Chronic Nonmalignant Pain Review box on p. 168).
• Over time, older adults may lose reliability in recalling and accurately reporting persistent pain. Older adults, especially those 75 years of age or older,
are at higher potential for too much or too little pain management, and it
is important to remember that these drugs have a higher peak and longer
duration of action in these patients than in their younger counterparts.
CHAPTER 11 Analgesic Drugs
187
Fig. 11.4 Wong-Baker ‘OUCH’ FACES Scale. This pain assessment scale is used in Canada for children
3 years and older. https://wongbakerfaces.org/.
• Smaller dosages of opioids are generally indicated for older adults because
of their increased sensitivity to the CNS depressant effects of the drugs and
diminished kidney and liver function. Paradoxical (opposite) reactions and
unexpected reactions may be more likely to occur in patients of this age group.
• In older adult male patients, benign prostatic hypertrophy or obstructive
urinary diseases should be considered because of the urinary retention
associated with the use of opioids. Urinary outflow can become further
diminished in these patients and result in adverse reactions or complications. The physician may need to make dosage adjustments.
• Polypharmacy is often a problem in older adults; therefore, have a complete
list of all medications the patient is currently taking, and assess for drug
interactions and treatment (drug) duplication.
• Frequent assessments of older adult patients are needed. Pay attention to
level of consciousness, alertness, and cognitive ability while ensuring that
the environment is safe by keeping a call bell or light at the bedside. Using
bed alarms is indicated where available.
• Decreased circulation causes variation in the absorption of IM or IV dosage
forms and often results in the slower absorption of parenteral forms of opioids.
• Encourage older adults to ask for medications if needed. They often hesitate to ask for pain medication because they do not want to bother the
nurse or give in to pain.
• NSAIDs must be used with caution because of their potential for renal and
GI toxicity. Acetaminophen is the drug of choice for relieving mild to moderate pain but with cautious dosing because of liver and kidney concerns. The
oral route of administration is preferred for analgesia. The regimen should
be as simple as possible to enhance adherence. Be sure to note, report,
and document any unusual reactions to the opioid drugs. Hypotension and
respiratory depression may occur more frequently in older adults taking opioids; thus, careful vital sign monitoring is needed.
Opioid Antagonists
Remember that opioid antagonists are used mainly in reversing respiratory depression secondary to opioid overdosage.
Naloxone may be used in patients of all ages, including neonates
and children. Assess and document vital signs before, during,
and after the use of the antagonist so that the therapeutic effects
can be further assessed and documented and the need for further doses determined. In addition, remember that the antagonist drug may not work with just one dosing and that repeated
doses are generally needed to reverse the effects of the opioid.
See the pharmacology section for information about contraindications, cautions, and drug interactions.
NURSING DIAGNOSES
• Reduced gas exchange resulting from opioid-induced CNS
effects and respiratory depression
• Acute pain resulting from specific disease processes or conditions and other pathologies leading to various levels and
types of pain
• Persistent pain resulting from various disease processes, conditions, or syndromes causing pain
• Constipation resulting from the CNS-depressant effects on
the GI system
• Inadequate knowledge resulting from lack of familiarity with
opioids, their use, and their adverse effects
PLANNING
Opioid Agonist–Antagonists
Goals
In patients taking opioid agonist–antagonists, assess vital signs
with attention to respiratory rate and breath sounds. Opioid
agonist–antagonists still possess opioid agonist effects, and
therefore the assessment information regarding opioids is applicable to these drugs as well.
It is also important to remember during assessment that these
drugs are still effective analgesics and will have CNS-depressant
effects but are subject to the analgesic ceiling effect (see earlier
definition). Given the action of these drugs, the assessment may
help determine whether the patient misuses opioids. This information is important because the simultaneous administration of
agonist–antagonists with another opioid will lead to reversal of
analgesia and possible opioid withdrawal. Age is another factor
to assess because these drugs are not recommended for use in
patients 18 years of age or younger. See previous discussion for
a listing of contraindications, cautions, and drug interactions.
• Patient will regain or maintain a respiratory rate between 10
and 20 breaths per minute without respiratory depression.
• Patient will state adequate acute pain relief associated with
appropriate analgesic drug therapy regimen.
• Patient will experience relief from persistent pain associated
with appropriate pharmacological therapy regimen.
• Patient will identify measures to help maintain normal bowel
elimination patterns and avoid or minimize opioid-induced
constipation.
• Patient will demonstrate adequate knowledge about the analgesic or other drug therapy and nondrug regimen.
Expected Patient Outcomes
• Patient states correct technique for coughing and deep
breathing and adequate fluid intake while taking opioids or
other analgesics for pain.
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PART 2 Drugs Affecting the Central Nervous System
• Patient’s respiratory rate is within normal depth, rate, and
patterns with clearing breath sounds.
• Patient relates increased comfort levels as seen by decreased
use of analgesics, increased activity and performance of
activities of daily living, decreased reports of acute pain, as
well as decreased levels of pain as rated on a scale of 1 to 10.
• Patient uses nonpharmacological measures such as relaxation
therapy, distraction, and music therapy to help improve comfort
and enhance any drug therapy regimens for persistent pain.
• Patient states various measures to help minimize or avoid the
occurrence of constipation with forcing of fluids, increasing
fibre in the diet, and improving mobility.
• Patient reports appropriate use of analgesics with minimal
complications or adverse effects.
• Patient states rationale for the use, action, and therapeutic
effects associated with analgesic drugs for management of
acute or persistent pain.
• Patient states rationale for the use of nondrug approaches to
pain management.
• Patient states importance of taking medication as prescribed.
IMPLEMENTATION
Once the cause of pain has been diagnosed or other assessment
and data gathering have been completed, begin pain management
immediately and aggressively, according to the needs of each
individual patient and situation. Pain management is varied and
multifaceted and needs to incorporate pharmacological and nonpharmacological approaches (see Box 11.1 and Natural Health
Products: Feverfew box). Negotiate with patients by integrating
religious ceremonies and traditional healing practices into pain
care, rather than imposing Western cultural approaches. Pain
management strategies must also include consideration for the
type of pain and pain rating as well as pain quality, duration, and
precipitating factors, and interventions that help the pain. Some
general principles of pain management are as follows:
NATURAL HEALTH PRODUCTS
Feverfew (Chrysanthemum parthenium)
Overview
A member of the marigold family known for its anti-inflammatory properties
Common Uses
Treatment of migraine headaches, menstrual cramps, inflammation, and fever
Adverse Effects
Nausea, vomiting, constipation, diarrhea, altered taste sensations, muscle
stiffness, and joint pain
Potential Drug Interactions
Possible increase in bleeding with use of aspirin and other NSAIDs, dipyridamole, and warfarin sodium
Contraindications
Contraindicated in those with allergies to ragweed, chrysanthemums, and
marigolds, as well as those about to undergo surgery
1. Individualize a plan of care based on the patient as a holistic and cultural being (see Ethnocultural Implications: The
Patient Experiencing Pain box, p. 166).
2. Manage mild pain with the use of nonopioid drugs such as
acetaminophen, tramadol hydrochloride, and NSAIDs (see
Chapter 49).
3. Manage moderate to severe pain with a stepped approach,
using opioids. Other analgesics or types of analgesics may
be used in addition to other categories of medication (see
pharmacology discussion).
4. Administer analgesics as ordered but before the pain gets out
of control.
5. Always consider the use of nonpharmacological comfort
measures (see Box 11.1) such as homeopathic and folk remedies, exercise, distraction, music or pet therapy, massage, and
transcutaneous electrical stimulation. Although not always
effective, these measures may prove beneficial for some
patients. See Patient Teaching Tips for more information
regarding analgesics.
Nonopioids
Give nonopioid analgesics as ordered or as indicated for fever or
pain. Acetaminophen should be taken as prescribed and within
the recommended dosage range over a 24-hour period because
of the risk of liver damage and acute toxicity. If a patient is taking
other OTC medications with acetaminophen, he or she needs to
understand the importance of reading the labels (of other medications) carefully to identify the total amount of acetaminophen
taken and any other drug–drug interactions. In educating the
patient, emphasize the signs and symptoms of acetaminophen
overdose: bleeding, loss of energy, fever, sore throat, and easy
bruising (because of hepatotoxicity). These signs and symptoms
must be reported immediately by the patient, family member,
or caregiver to the nurse or health care provider. Any worsening
or change in the nature or characteristic of pain must also be
reported.
If the medication is taken by suppository, once the suppository is unwrapped, cold water may be run over it to moisten it
for easier insertion. The suppository is inserted into the rectum
using a gloved finger and water-soluble lubricating gel if necessary. Acetaminophen tablets may be crushed if needed. Adult
patients who take more than 4 000 mg/day are at potential for
acute hepatotoxicity. Death may occur after ingestion of more
than 15 g. Liver damage from acetaminophen may be minimized by timely dosing with acetylcysteine (see previous discussion). If acetylcysteine is indicated, warn the patient about
the drug’s foul taste and odour; many patients report that the
drug smells and tastes like rotten eggs. Acetylcysteine is better
tolerated if it is disguised by mixing with a drink such as cola or
flavoured water to increase its palatability. Use of a straw may
help minimize contact with mucous membranes of the mouth
and is recommended. This antidote may be given through a
nasogastric tube or intravenously, if necessary.
Tramadol may cause drowsiness, dizziness, headache, nausea, constipation, and respiratory depression. If dizziness,
blurred vision, or drowsiness occurs, be sure to assist the
CHAPTER 11 Analgesic Drugs
patient with ambulation to minimize the risk of fall and injury.
Educate the patient about injury prevention, including the need
to dangle the feet over the edge of the bed before full ambulation, changing positions slowly, and asking for assistance when
ambulating. In addition, while the patient is taking tramadol, as
well as any other analgesics, and especially opioids, the patient
needs to avoid any tasks that require mental clarity and alertness. Increasing fluids and fibre in the diet may help with constipation. Use of flat cola, ginger ale, or dry crackers may help to
minimize nausea.
Opioids
When opioids (and other analgesics) are prescribed, administer the drug as ordered after checking for the “rights” of medication administration (see Chapter 1). After the health care
provider’s order has been double-checked, and before administering another dose, closely examine the medication profile
and documentation to determine the last time the medication
was given. Monitor the patient’s vital signs at frequent intervals,
with special attention to respiratory changes. A respiratory rate
of 10 breaths/min (some protocols still adhere to the parameter of 12 breaths/min) may indicate respiratory depression and
must be reported to the health care provider. The drug dosage,
frequency, or route may need to be changed or an antidote (opioid antagonist) given if respiratory depression occurs. Naloxone
must always be available, especially with the use of IV or other
parenteral dosage forms of opioids, such as PCA (see Chapter
10 and the discussion to follow) or epidural infusions. Naloxone
is indicated to reverse CNS depression, specifically respiratory
depression, but remember that this antidote also reverses analgesia. Monitor the patient’s urinary output as well; it should be
at least 720 mL/24 hr. Monitor bowel sounds during therapy;
decreased peristalsis may indicate the need for a dietary change,
such as increased fibre, or use of a stool softener or mild laxative. Assess the patient’s pupillary reaction to light. Pinpoint
pupils indicate a possible overdose.
Opioids or any analgesic must be given before the pain
reaches its peak to help maximize the drug’s effectiveness.
Once the drug is administered, return at the appropriate
time (taking into consideration the times of onset and peak
effect of the drug and the route) to assess the effectiveness
of the drug or other interventions as well as observe for the
presence of adverse effects (see previous discussion of pain
assessment tools). In regard to the route of administration,
the recommendation is that oral dosage forms be used first,
but only if ordered and if there is no nausea or vomiting.
Taking the dose with food may help minimize GI upset.
Should nausea or vomiting be problematic, an antiemetic
may be ordered for administration before or with the dosing
of medication. Crucial safety measures include keeping bed
side rails up, turning bed alarms on (depending on facility
policies and procedures), and making sure the call bell or
alarm is within the patient’s reach. These measures will help
to prevent falls or injury resulting from opioid use. Opioids
and similar drugs lead to CNS depression with possible confusion, altered sensorium or alertness, hypotension, and
altered motor functioning. Because of these drug effects, all
189
patients are at potential for falls or injury, and older adults
are at higher risk (see Special Populations: Older Adults:
Use of Opioids box). See Table 11.10 below for more specific information concerning the handling of controlled substances and opioid counts.
When managing pain with morphine sulphate, meperidine
hydrochloride, and similar opioid drugs, withhold the dose and
contact the health care provider if there is any decline in the
patient’s condition or if vital signs are abnormal (see parameters mentioned earlier), and especially if the respiratory rate is
less than 10 breaths/min. IM injections of analgesics are rarely
used because of the availability of other effective and convenient
dosage forms, such as PCA pumps, transdermal patches, constant subcut infusions, and epidural infusions. For transdermal
patches (e.g., transdermal fentanyl), two systems are used. The
older type of patch contains a reservoir system consisting of four
layers, beginning with the adhesive layer and ending with the
protective backing. Between these two layers are the permeable
rate–controlling membrane and the reservoir layer, which holds
the drug in a gel or liquid form. The newer type of patch has
a matrix system consisting of two layers—one containing the
active drug with the releasing and adhesive mechanisms, and
the other a protective, impermeable backing layer. The advantages of the matrix system over the reservoir system are that the
patch is slimmer and smaller, it is more comfortable, it is worn
for up to 7 days (the older reservoir system patch is worn for up
to 3 to 4 days), and it appears to result in more constant serum
drug levels. In addition, the matrix system is alcohol free; the
alcohol in the reservoir system often irritates the patient’s skin.
It is important to know what type of delivery system is being
used so that proper guidelines are followed to enhance the system’s and drug’s effectiveness.
Apply transdermal patches to only a clean, nonhairy area.
When the patch is changed, place the new patch on a new site, but
only after the old patch has been removed and the site cleansed
of any residual medication. Rotation of sites helps decrease irritation and enhance drug effects. Transdermal patches require
special discarding of old and used patches (see Preventing
Medication Errors: Fentanyl Transdermal Patches box on p.
174). Transdermal systems are beneficial for the delivery of
many types of medications, especially analgesics, and have the
benefits of allowing multiday therapy with a single application,
avoiding first-pass metabolism, improving patient adherence,
and minimizing frequent dosing. However, the patient should
be watched carefully for the development of any type of contact
dermatitis caused by the patch (contact the health care provider
immediately if this occurs) and maintain a pain journal when
at home. Journal entries are a valid source of information for
the nurse, other health care providers, the patient, and family
members to assess the patient’s pain control and to monitor the
effectiveness of not only transdermal analgesia but any medication regimen.
With the IV administration of opioid agonists, follow the
manufacturer’s guidelines and institutional policies regarding
specific dilution amounts and solution as well as the time period
for infusion. When PCA is used, the amounts and times of dosing should be noted in the appropriate records and tracked
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PART 2 Drugs Affecting the Central Nervous System
TABLE 11.10
Opioid Administration Guidelines
Opioid
Nursing Administration
buprenorphine and butorphanol tartrate
codeine phosphate
When giving IV, infuse over the recommended time (usually 3–5 min). Always assess respirations. Give IM as ordered.
Give PO doses with food to minimize gastrointestinal tract upset; ceiling effects occur with oral codeine phosphate,
resulting in no increase in analgesia with increased dosage.
Administer parenteral doses as ordered and per manufacturer’s guidelines in regard to mg/min to prevent CNS
depression and possible cardiac or respiratory arrest. Transdermal patches come in a variety of dosages. Be sure to
remove residual amounts of the old patch prior to application of a new patch. Dispose of patches properly to avoid
inadvertent contact with children or pets. A fentanyl citrate sublingual effervescent tablet (Fentora®) is available for
the management of breakthrough pain in patients with cancer that are 18 years of age and older and who are already
receiving and are tolerant to continuous opioid therapy for their persistent baseline cancer.
May be given subcut, rectally, IV, IM, or PO.
Given by a variety of routes: IV, IM, or PO; highly protein bound, so watch for interactions and toxicity. Monitor older
adults for increased sensitivity.
Available in a variety of forms: subcut, IM, IV, PO, extended, and immediate release, and for epidural infusion. Always
monitor respiratory rate.
IV dosages of 10 mg given undiluted over 5 min
Antagonist given for opioid overdose; 0.4 mg usually given IV over 15 sec or less. Reverses analgesia as well.
Often mixed with acetaminophen or aspirin; PO and suppository dosage forms. Available in both immediate and
sustained-release tabs
PO, subcut, IV, and IM forms; mixed agonist–antagonist; IV dose of 5 mg to be given over 1 min
fentanyl
hydromorphone hydrochloride
meperidine hydrochloride
morphine sulphate
nalbuphine hydrochloride
naloxone hydrochloride
oxycodone hydrochloride
pentazocine
CNS, Central nervous system; IM, intramuscular; IV, intravenous; PO, oral; subcut, subcutaneous.
by appropriate personnel. The fact that a pump is being used,
however, does not mean that it is 100% reliable or safe. Closely
monitor and frequently check all equipment. Additionally, frequently monitor pain levels, response to medication, and vital
signs with the use of other parenteral opioid administration.
Always follow dosage ranges for all opioid agonists and agonist–
antagonists and pay special attention to the dosages of morphine and morphine-like drugs. For IV infusions, the nurse is
responsible for monitoring the IV needle site and documenting
any adverse effects or complications. Another point to remember when administering opioids, as well as other analgesics, is
that each medication has a different onset of action, peak, and
duration of action, with the IV route producing the most rapid
onset (i.e., within minutes) (see Table 11.10).
To reverse an opioid overdose or opioid-induced respiratory depression, an opioid antagonist such as naloxone must be
administered. If naloxone is used, 0.4 to 2 mg should be given
intravenously in its undiluted form and should be administered
over 15 seconds (or as ordered); if reconstitution is needed, 0.9%
NaCl or 5% dextrose injection should be used (see Table 11.8).
However, the guidelines in the package insert should also be followed. Emergency resuscitative equipment should be nearby in
the event of respiratory or cardiac arrest.
Opioid Agonist–Antagonists
When giving agonist–antagonists, remember that they react differently depending on whether they are given by themselves or
with other drugs. When administered alone, they are effective
analgesics because they bind with opiate receptors and produce
an agonist effect (see discussion in pharmacology section). If
given at the same time with other opioids, however, they lead to
reversal of analgesia and acute withdrawal because of the blocking of opiate receptors. Be careful to check dosages and routes
as well as perform the interventions mentioned for opioid agonist drugs, including closely assessing vital signs, especially
respiratory rate. Emphasize with the patient the importance
of reporting any dizziness, unresolved constipation, urinary
retention, and sedation. See Table 11.7 for additional adverse
effects of opioid agonists as they are similar to the opioid agonist–antagonist drugs. Other points to emphasize include that
the drug also has the ability to reverse analgesia as well as precipitate withdrawal (if taken with other opioid agonists). A list
of other opioid agonists must be shared with the patient as well.
Opioid Antagonists
Opioid antagonists must be given as ordered and be readily
available, especially when the patient is receiving PCA with
an opioid, is opioid naive, or is receiving continuous doses
of opioids. Several doses of these drugs are often required to
ensure adequate opioid agonist reversal (see earlier discussion).
Encourage patients to report any nausea or tachycardia.
General Considerations
You are always responsible and accountable for maintaining a
current, updated knowledge base on all forms of analgesics as
well as protocols for pain management, with focus on the specific drug(s) as well as differences in the treatment of mild to
moderate pain, severe pain, and pain in special situations (e.g.,
cancer pain). The WHO’s three-step analgesic ladder provides a
standard for pain management in patients with cancer and must
be reviewed and considered, as needed. Dosing of medications
for pain management is important to the treatment regimen.
Once a thorough assessment has been performed, it is best to
treat the patient’s pain before it becomes severe, which is the
rationale for considering pain the fifth vital sign. When pain is
present for more than 12 hours a day, analgesic doses are individualized and best administered around the clock rather than
on an as-needed basis, while always staying within safe practice
guidelines for each drug used. Around-the-clock (or scheduled)
dosing maintains steady-state levels of the medication and
CHAPTER 11 Analgesic Drugs
TABLE 11.11
191
Drugs Not Recommended for Treatment of Cancer Pain
Class
Drug
Reason for Not Recommending
Opioids with dosing around the clock
meperidine
Miscellaneous
cannabinoids
Opioid agonist–antagonists
pentazocine
butorphanol tartrate
nalbuphine
buprenorphine
naloxone
naltrexone
Benzodiazepines
(e.g., alprazolam)
Short (2–3 hr) duration of analgesia; administration may lead to CNS toxicity (tremor, confusion, or seizures)
Adverse effects of dysphoria, drowsiness, hypotension, and bradycardia, which preclude
their routine use as analgesics; may be indicated for use in treating severe chemotherapy-induced nausea and vomiting
May precipitate withdrawal in opioid-dependent patients; analgesic ceiling effect; possible
production of unpleasant psychological
adverse effects, including dysphoria, delusions, and hallucinations
Analgesic ceiling effect; can precipitate withdrawal if given with an opioid
Reverses analgesia as well as CNS depressant effects, such as respiratory depression
Opioid antagonists
Anxiolytics (as monotherapy) or
sedative–hypnotics (as monotherapy)
Barbiturates
Analgesic properties not associated with these drugs except in some situations of neuropathic pain; common risk of sedation, which may put some patients at higher potential for
neurological complications
Analgesic properties not demonstrated; sedation is problematic and limits use
prevents drug troughs and pain escalation. No given dosage of
an analgesic will provide the same level of pain relief for every
patient; thus, there is a need for a process of titration, upward
or downward, to be carried out based on the individual’s needs.
Aggressive titration may be necessary in difficult pain control
cases and in cancer pain situations. Patients with severe pain,
metastatic pain, or bone metastasis pain may need increasingly
higher doses of analgesic. These special pain situations may
require an opiate such as morphine that needs to be titrated
until the desired response is achieved or until adverse effects
occur. A patient-rated pain level of less than 4 on a scale of 1 to
10 is considered an indication of effective pain relief.
If pain is not managed adequately by monotherapy, other
drugs or adjuvants may need to be added to enhance analgesic efficacy. This includes the use of NSAIDs (for analgesic
and anti-inflammatory effects), acetaminophen (for analgesic
effects), corticosteroids (for mood elevation and anti-inflammatory, antiemetic, and appetite-stimulation effects), anticonvulsants (for treatment of neuropathic pain), tricyclic
antidepressants (for treatment of neuropathic pain and opioid-potentiating effects), neuroleptics (for treatment of persistent pain syndromes), local anaesthetics (for treatment of
neuropathic pain), hydroxyzine hydrochloride (for mild antianxiety properties as well as sedating effects and antihistamine
and mild antiemetic actions), or psychostimulants (for reduction of opioid-induced sedation when opioid dosage adjustment is not effective). See Table 11.11 for a listing of drugs that
should not be used in patients experiencing cancer pain.
Dosage forms are also important, especially with persistent
pain and cancer pain. Oral administration is always preferred
but is not always tolerated by the patient and may not even be
a viable option for pain control. If oral dosing is not appropriate, less invasive routes of administration include rectal and
transdermal routes. Rectal dosage forms are safe, inexpensive,
effective, and helpful if the patient is experiencing nausea or
vomiting or altered mental status; however, this route is not
suitable for those with diarrhea, stomatitis, or low blood cell
counts. Transdermal patches (e.g., the buprenorphine transdermal patch) may provide up to 7 days of pain control but are not
for rapid dose titration and are used only when stable analgesia
has been previously achieved. Long-acting forms of morphine
and fentanyl may be delivered via transdermal patches when a
longer duration of action is needed. Intermittent injections or
continuous infusions via the IV or subcut routes are often used
for opioid delivery and may be administered at home in special
pain situations, such as in hospice care and in persistent cancer
pain management. Subcut infusions are often used when there
is no IV access. PCA pumps may be used to help deliver opioids
intravenously, subcutaneously, or even intraspinally and can be
managed in home health care or hospice care for the patient at
home. Use of the intrathecal or epidural route requires special
skill and expertise, and delivery of pain medications using these
routes is available only from certain home health care agencies
for at-home care. The main reason for long-term intraspinal
opioid administration is intractable pain. Transnasal dosage
forms are approved only for butorphanol tartrate, an agonist–
antagonist drug, and this dosage form is generally not used or
recommended. Regardless of the specific drug or dosage form
used, a fast-acting rescue drug needs to be ordered and available for patients with cancer pain or other special challenges in
pain management. Regardless of the drug(s) used for the pain
management regimen, always remember that individualization
of treatment is one of the most important considerations for
effective and quality pain control. Also consider implementing
the following:
• At the initiation of pain therapy, conduct a review of all relevant histories, laboratory test values, nurse-related charting
entries, and diagnostic study results in the patient’s medical
record.
• If there are underlying problems, consider them while never
forgetting to treat patients with dignity and respect. Never let
compounding variables or any other problems overshadow
the fact that there is a patient who is in pain and deserving of
safe, quality care.
• Develop goals for pain management in conjunction with
the patient, family members, significant others, or caregivers. These goals include improving the level of comfort with
increased levels of activities of daily living and ambulation.
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PART 2 Drugs Affecting the Central Nervous System
• Collaborate with other members of the health care team to
select a regimen that will be easy for the patient to follow while
in the hospital and, if necessary, at home (e.g., for patients
with cancer and other patients experiencing persistent pain).
• Be aware that most regimens for acute pain management
include treatment with short-acting opioids plus the addition of other medications such as NSAIDs.
• Be familiar with equianalgesic doses of opioids because lack
of knowledge of equivalencies may lead to inadequate analgesia or overdose.
• Use an analgesic appropriate for the situation (e.g., short-acting opioids for severe pain secondary to a myocardial infarction, surgery, or kidney stones). For cancer pain, the regimen
usually begins with short-acting opioids with eventual conversion to controlled-release formulations.
• Use preventive measures to manage adverse effects. In addition,
switch to another opioid as soon as possible if the patient finds
that the medication is not controlling the pain adequately.
• Consider the option of analgesic adjuvants, especially in
cases of persistent pain or cancer pain; these might include
other prescribed drugs such as NSAIDs, acetaminophen,
corticosteroids, anticonvulsants, tricyclic antidepressants,
neuroleptics, local anaesthetics, hydroxyzine hydrochloride,
or psychostimulants. Over-the-counter drugs and natural
health products may also be helpful.
• Be alert to patients with special needs, such as patients with
breakthrough pain. Generally, the drug used to manage such
pain is a short-acting form of the longer-acting opioid being
given (e.g., immediate-release morphine for breakthrough
pain while sustained-release morphine is also used).
• Identify community resources that can assist the patient,
family members, or significant others. These resources may
include various websites for patient education such as http://
www.canadianpainsociety.ca, http://www.chronicpaincanada.com, and http://www.iasp-pain.org. Many other pain
management sites may be found on the Internet by searching
using the terms pain, pain clinic, or pain education and looking for patient-focused materials or sites.
• Conduct frequent online searches to remain current on the
topics of pain management, pain education, drug and nondrug
therapeutic regimens for pain, and special pain situations.
• Because fall prevention is of utmost importance in patient
care (after the ABCs [airway, breathing, circulation] of care
are addressed), monitor the patient frequently after an analgesic is given. Frequent measurement of vital signs, inclusion of the patient in a frequent watch program, or use of bed
alarms is encouraged.
EVALUATION
Positive therapeutic outcomes of acetaminophen use are
decreased symptoms, including decreased fever and pain.
Monitor for adverse reactions of anemias and liver problems
due to hepatotoxicity, and report patient reports of abdominal
pain or vomiting to the health care provider. During and after
the administration of nonopioid analgesics such as tramadol,
opioids, and mixed opioid agonists, monitor the patient for both
therapeutic effects and adverse effects, frequently and as needed.
Therapeutic effects of analgesics include increased comfort
periods as well as decreased reports of pain, with improvements
in performance of activities of daily living, appetite, and sense
of well-being. Monitoring for adverse effects varies with each
drug (see earlier discussions), but adverse effects may consist
of nausea, vomiting, constipation, dizziness, headache, blurred
vision, decreased urinary output, drowsiness, lethargy, sedation, palpitations, bradycardia, bradypnea, dyspnea, and hypotension. If vital signs change, the patient’s condition declines,
or pain continues, the health provider should be contacted
immediately, and the patient closely monitored. Respiratory
depression may be manifested by a respiratory rate of less than
10 breaths/min, dyspnea, diminished breath sounds, or shallow
breathing. Include a review of the effectiveness of multimodal
and nonpharmacological approaches to pain management in
your evaluation.
CASE STUDY
Opioid Administration
You are assigned to care for a patient, Daphna, who is in the terminal stage of
breast cancer. As a community health care nurse, you have many responsibilities; however, you have not cared for many patients who are in the terminal
stages of their illness. In fact, most of your patients are postoperative and
have only required assessments, dressing changes, and wound care.
Daphna is 48 years of age and underwent bilateral mastectomy 4 years ago.
She had lymph node involvement at the time of surgery and was recently diagnosed with metastasis to the bone. She has been taking sustained-release
oxycodone (one 10-mg tab every 12 hours) at home but is not sleeping through
the night and is now reporting increasing pain to the point that her quality of
life has decreased significantly. She wants to stay at home during the terminal
stage of her illness but needs to have adequate and safe pain control. Her husband of 18 years is supportive. They have no children. They are both university
graduates and have medical insurance.
1. Daphna’s recent increase in pain has been attributed to bone metastasis
in the area of the lumbar spine. Currently, oxycodone is not beneficial, and
you need to advocate for Daphna to receive adequate pain relief. When
discussing her pain medications with her health care provider, what type
of medication would you expect to be ordered to relieve the bone pain, and
what is the rationale for this recommendation? Provide references from
within this chapter for the selection of the specific opioid drug.
2. Daphna’s husband confides in you that he is worried that she will become
addicted to the new medication. He is not sure he agrees with round-theclock dosing. How do you address his concerns?
3. What should Daphna’s husband do if he thinks that Daphna has had an
overdose?
For answers, see http://evolve.elsevier.com/Canada/Lilley/pharmacology/.
CHAPTER 11 Analgesic Drugs
PATIENT TEACHING TIPS
• Capsaicin is a topical product made from different types of
peppers that may help with muscle pain and joint or nerve
pain. It may cause local, topical reactions, including burns
and blistering, so be sure to share information with the
patient about its safe use.
• Opioids are not to be used with alcohol or with other CNS
depressants, unless ordered, because of worsening of the
depressant effects.
• A holistic approach to pain management may be appropriate, with the use of complementary modalities, including the
following: biofeedback, imagery, relaxation, deep breathing,
humour, pet therapy, music therapy, massage, use of hot or
cold compresses, and use of herbal products.
• Dizziness, difficulty breathing, low blood pressure, excessive
sleepiness (sedation), confusion, or loss of memory must be
promptly reported to the nurse or other health care provider.
• Opioids may result in constipation, so encouraging fluids
(up to 3 L/day unless contraindicated), increased fibre consumption, and exercise as tolerated are recommended. Stool
softeners may also be necessary.
• Report any nausea or vomiting. Antiemetic drugs may be
prescribed.
• Any activities requiring mental clarity or alertness may need
to be avoided if the patient is experiencing drowsiness or
sedation. Ambulate with caution or assistance as needed.
• It is important for the patient to share any history of addiction with health care providers, but when such a patient
•
•
•
•
193
experiences pain and is in need of opioid analgesia, understand that the patient has a right to comfort. Any further
issues with addiction may be managed during and after the
use of opioids. Keeping an open mind regarding the use
of resources, counselling, and other treatment options is
important in dealing with addictive behaviours.
If pain is problematic and not managed by monotherapy,
a combination of a variety of medications may be needed.
Other drugs that may be used include antianxiety drugs, sedatives, hypnotics, or anticonvulsants.
For the patient with cancer or special needs, the health care
provider will monitor pain control and the need for other
options for therapy or for dosing of drugs. For example, the
use of transdermal patches, buccal tablets, and continuous
infusions while the patient remains mobile or at home is
often helpful in pain management. It is also important to
understand that if morphine or morphine-like drugs are
being used, there is a potential for addiction; however, in specific situations, the concern for quality of life and pain management is more important than the concern for addiction.
Most hospitals have inpatient and outpatient resources such
as pain clinics. Patients need to constantly be informed and
aware of all treatment options and remain active participants
in their care for as long as possible.
Tolerance does occur with opioid use, so if the level of pain
increases while the patient remains on the prescribed dosage, the prescriber or health care provider must be contacted.
Dosages must not be changed, increased, or doubled unless
prescribed.
KEY POINTS
• Pain is individual and involves senses and emotions that are
unpleasant. It is influenced by age, ethnoculture, spirituality,
and all other aspects of the person.
• Pain is associated with actual or potential tissue damage and
may be exacerbated or alleviated depending on the treatment
and type of pain.
• Types of analgesics include the following:
• Nonopioids including acetaminophen and aspirin and
other NSAIDs
• Opioids, which are natural or synthetic drugs that either
contain or are derived from morphine (opiates) or have
opiate-like effects or activities (opioids), and opioid agonist–antagonist drugs
• Child dosages of morphine must be calculated cautiously
with close attention to the dose and kilograms of body
weight. Cautious titration of dosage upward is usually the
standard. Older adult patients may react to analgesics differently from what is expected, especially opioids and opioid
agonist–antagonists.
• Remember that older adult patients experience pain the
same as the general population, but they may be reluctant to
report pain. They also may metabolize opiates at a slower rate
and thus are at increased potential for adverse effects such as
sedation and respiratory depression. The best rule is to begin
with low dosages, re-evaluate often, and go slowly during
upward titration.
E X A M I N AT I O N R E V I E W Q U E S T I O N S
1. For best results when treating severe pain associated with
pathological spinal fractures resulting from metastatic bone
cancer, the nurse should remember that the best type of dosage schedule is to administer the pain medication in which
way?
a. As needed
b. Around the clock
c. On schedule during waking hours only
d. Around the clock, with additional doses as needed for
breakthrough pain
2. A patient is receiving an opioid via a PCA pump as part
of his postoperative pain management program. During
rounds, the nurse finds him unresponsive, with respirations
of 8 breaths/min and blood pressure of 102/58 mm Hg. After
stopping the opioid infusion, what should the nurse do next?
a. Notify the charge nurse
b. Draw arterial blood gases
c. Administer an opiate antagonist per standing orders
d. Perform a thorough assessment, including mental status
examination
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PART 2 Drugs Affecting the Central Nervous System
3. A patient with bone pain caused by metastatic cancer will
be receiving transdermal fentanyl patches. The patient asks
the nurse what benefits these patches have. The nurse’s best
response includes which of these features?
a. More constant drug levels for analgesia
b. Less constipation and minimal dry mouth
c. Less drowsiness than with oral opioids
d. Lower dependency potential and no major adverse effects
4. IV morphine is prescribed for a patient who has had surgery.
The nurse informs the patient that which common adverse
effects can occur with this medication? (Select all that apply.)
a. Diarrhea
b. Constipation
c. Pruritus
d. Urinary frequency
e. Nausea
5. Several patients have standard orders for acetaminophen,
as needed for pain. When the nurse reviews their histories
and assessments, it is discovered that one of the patients has
a contraindication to acetaminophen therapy. Which of the
following patients should receive an alternate medication?
a. A patient with a fever of 39.7°C
b. A patient admitted with deep vein thrombosis
c. A patient admitted with severe hepatitis
d. A patient who had abdominal surgery 1 week earlier
6. The nurse is administering an IV dose of morphine to a
48-year-old postoperative patient. The dose ordered is 3 mg
every 3 hours, as needed for pain. The medication is supplied in vials of 4 mg/mL. How much will be drawn into the
syringe for this dose?
7. An opioid analgesic is prescribed for a patient. The nurse
checks the patient’s medical history knowing this medication
is contraindicated in which disorder?
a. Renal insufficiency
b. Severe asthma
c. Liver disease
d. Diabetes mellitus
8. A patient with renal cancer needs an opiate for pain control.
Which opioid medication would be the safest choice for this
patient?
a. fentanyl
b. hydromorphone (Dilaudid)
c. morphine sulphate
d. methadone (Dolophine)
CRITICAL THINKING ACTIVITIES
1. The nurse is about to administer 5 mg of morphine intravenously to a patient with severe postoperative pain, as ordered.
What priority assessment data must be gathered before and
after administering this drug? Explain your answer.
2. A patient reports that the drugs he is receiving for severe
pain are not really helping. What is the nurse’s priority action
at this time?
3. A young woman is brought by ambulance to the emergency
department because she was found unconscious next to an
empty bottle of acetaminophen. While the medical team
assesses her, the nurse goes to question the family about the
situation. What is the most important piece of information
to know about this possible overdose?
For answers, see http://evolve.elsevier.com/Canada/Lilley/
pharmacology/.
E-LEARNING ACTIVITIES
Website
(http://evolve.elsevier.com/Canada/Lilley/pharmacology/)
• Answer Key—Textbook Case Studies
• Answer Key—Critical Thinking Activities
• Chapter Summaries—Printable
• Review Questions for Exam Preparation
• Unfolding Case Studies
REFERENCES
Health Canada. (2019a). Naloxone. Retrieved from https://www.
canada.ca/en/health-canada/services/substance-use/problematic-prescription-drug-use/opioids/naloxone.html.
Health Canada. (2019b). Health Canada recommends that children
and youth not use cough and cold products that contain opioids.
Retrieved from https://healthycanadians.gc.ca/recall-alert-rappelavis/hc-sc/2019/69080a-eng.php.
Chapman, J., & Arnold, J. K. (2019). Reye syndrome. [Updated 2019
Jan 17]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls
Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/
NBK526101/.
Health Canada. (2015). Summary safety review—Acetaminophen—
Liver injury. Retrieved from https://hpr-rps.hres.ca/reg-content/
summary-safety-review-detail.php?lang=en&linkID=SSR00120.
12
General and Local Anaesthetics
OBJECTIVES
After reading this chapter, the successful student will be able to
do the following:
1. Define anaesthesia.
2. Describe the basic differences between general and local
anaesthesia.
3. List the most commonly used general and local anaesthetics
and associated risks.
4. Discuss the differences between depolarizing
neuromuscular blocking drugs and nondepolarizing
blocking drugs and their impact on the patient.
5. Compare the mechanisms of action, indications, adverse
effects, routes of administration, cautions, contraindications,
and drug interactions of general anaesthesia and local
anaesthesia, and of drugs used for procedural sedation.
6. Develop a collaborative plan of care for patients before
anaesthesia (preanaesthesia), during anaesthesia, and
after anaesthesia (postanaesthesia), related to general
anaesthesia.
7. Develop a collaborative plan of care for patients undergoing
local anaesthesia or procedural sedation.
KEY TERMS
Adjunct anaesthetics Drugs used in combination with
anaesthetic drugs to control the adverse effects of
anaesthetics or to help maintain the anaesthetic state in the
patient (See balanced anaesthesia). (p. 196)
Anaesthesia The loss of the ability to feel pain, resulting from
the administration of an anaesthetic drug. (p. 196)
Anaesthetics Drugs that depress the central nervous system
(CNS) or peripheral nerves to produce decreased sensation,
loss of sensation, or muscle relaxation. (p. 196)
Balanced anaesthesia The practice of using combinations
of different classes of drugs rather than a single drug to
produce anaesthesia. (p. 196)
General anaesthesia A drug-induced state in which CNS
nerve impulses are altered to reduce pain and other
sensations throughout the entire body. It normally involves
complete loss of consciousness and depression of normal
respiratory drive. (p. 196)
Local anaesthesia A drug-induced state in which peripheral
or spinal nerve impulses are altered to reduce or eliminate
pain and other sensations in tissues innervated by these
nerves. (p. 196)
Malignant hyperthermia A genetically linked, major adverse
reaction to general anaesthesia characterized by a rapid rise
in body temperature as well as tachycardia, tachypnea, and
sweating. (p. 198)
Overton–Meyer theory A theory that describes the
relationship between the lipid solubility of anaesthetic drugs
and their potency. (p. 197)
Procedural sedation A milder form of general anaesthesia
that causes partial or complete loss of consciousness
but does not generally reduce normal respiratory drive
(formerly referred to as conscious sedation or moderate
sedation). (p. 200)
Spinal anaesthesia Local anaesthesia induced by injection
of an anaesthetic drug near the spinal cord to anaesthetize
nerves that are distal to the site of injection (also called
intraspinal anaesthesia). (p. 201)
DRUG PROFILES
dexmedetomidine hydrochloride, p. 200
halothane, p. 198
isoflurane, p. 199
ketamine hydrochloride, p. 199
lidocaine (lidocaine hydrochloride*), p. 203
nitrous oxide, p. 199
pancuronium (pancuronium bromide*), p. 206
propofol, p. 199
sevoflurane, p. 199
succinylcholine, p. 205
vecuronium bromide, p. 206
Key drug
* Full generic name is given in parentheses. For the purposes of this text, the more common, shortened name is used.
195
196
PART 2 Drugs Affecting the Central Nervous System
HIGH-ALERT DRUGS
dexmedetomidine, p. 200
ketamine, p. 199
propofol, p. 199
vecuronium, p. 206
succinylcholine, p. 205
OVERVIEW
Anaesthetics are drugs that reduce or eliminate pain by
depressing the central nervous system (CNS) or the peripheral nervous system (PNS). This state of reduced neurological
function is called anaesthesia. Anaesthesia is further classified
as general or local. General anaesthesia involves complete loss
of consciousness, loss of body reflexes, elimination of pain and
other sensations throughout the entire body, and skeletal and
smooth muscle paralysis, including paralysis of respiratory
muscles. Local anaesthesia does not involve paralysis of respiratory function but does involve elimination of pain sensation
in the tissues innervated by anaesthetized nerves. Functions of
the autonomic nervous system, which includes the sympathetic
and parasympathetic nervous system, may also be affected.
GENERAL ANAESTHETICS
General anaesthetics are drugs that induce general anaesthesia and are most commonly used to induce anaesthesia during
surgical procedures. General anaesthetics are given only under
controlled situations by anaesthesiologists. General anaesthesia
is achieved by the use of one or more drugs. Often a synergistic combination of drugs is used, which allows lower doses of
each drug and better control of the patient’s anaesthetized state.
Inhalational anaesthetics are volatile liquids or gases that are
vaporized or mixed with oxygen to induce anaesthesia. For a
historical perspective on general anaesthesia, see Box 12.1.
Parenteral anaesthetics (Table 12.1) are given intravenously
and are used for induction or maintenance of general anaesthesia, for induction of amnesia, and as adjuncts to inhalation-type
anaesthetics (Table 12.2). The specific goal varies with the drug.
Common intravenous (IV) anaesthetic drugs include drugs
classified solely as general anaesthetics, such as propofol.
Adjunct anaesthetics, or simply adjuncts, are also used.
Adjunct is a general term for any drug that enhances clinical therapy when used simultaneously with another drug.
Adjunct drugs can be thought of as “helper drugs” when their
use complements the use of any other drug(s). They are used
simultaneously with general anaesthetics for anaesthesia initiation (induction), sedation, reduction of anxiety, and amnesia.
Adjuncts include neuromuscular blocking drugs (NMBDs; see
Neuromuscular Blocking Drugs later in this chapter), sedative–
hypnotics or anxiolytics (see Chapter 13) such as propofol (this
chapter), benzodiazepines (e.g., diazepam, midazolam), barbiturates (e.g., thiopental, methohexital; see Chapter 13), opioid
analgesics (e.g., morphine sulphate, fentanyl citrate, sufentanil citrate; see Chapter 11), anticholinergics (e.g., atropine
sulphate; see Chapter 22), and antiemetics (e.g., ondansetron
BOX 12.1
Perspective
General Anaesthesia: A Historical
Until recently, general anaesthesia was described as having several definitive stages. This was especially true with the use of many of the ether-based
inhaled anaesthetic drugs. Features of these distinctive stages were easily
observable to the trained eye. They included specific physical and physiological changes that progressed gradually and predictably with the depth of the
patient’s anaesthetized state. Gradual changes in pupil size, progression from
thoracic to diaphragmatic breathing, vital sign changes, and several other
changes all characterized the various stages. Newer inhalational and IV general anaesthetic drugs, however, often have a much more rapid onset of action
and body distribution. As a result, the stages of anaesthesia once observed
with older drugs are no longer sufficiently well defined to be observable. Thus,
the concept of stages of anaesthesia is an outdated one in most modern surgical facilities. Registered nurses who pursue advanced training to become certified registered nurse anaesthesiologists often find this to be a rewarding and
interesting area of nursing practice. In Canada, there is currently one program
providing training for nurse practitioners in anaesthesia care (NP-A). The role
of an anaesthesia assistant is also relatively new in Canada; however, training
programs are not limited to registered nurses. Regulations about the role of
anaesthesia assistants vary among provinces and territories. In addition, perianaesthesia nursing is a recognized specialty at a national level. Nurses who
successfully write the certification exam are recognized for their knowledge
and expertise by the Canadian Nurses Association.
TABLE 12.1
Anaesthetics
Parenteral General
Generic Name
Trade Name
Ketamine
Ketalar®
Propofol
Diprivan®
Thiopental
Pentothal®
TABLE 12.2
Drugs
Inhaled General Anaesthetic
Generic Name
Trade Name
Inhaled Gas
nitrous oxide (“laughing gas”)
Inhaled Volatile Liquid
desflurane
Suprame®
halothane
Halothane®
isoflurane
Forane®
sevoflurane
Sevorane AF®
hydrochloride dihydrate; see Chapter 41). Note that propofol can be used as a general anaesthetic or sedative–hypnotic,
depending on the dose. The simultaneous use of both general anaesthetics and adjuncts is called balanced anaesthesia.
Common adjunct anaesthetic drugs are listed in Table 12.3.
Mechanism of Action and Drug Effects
Many theories have been proposed to explain the actual
mechanism of action of general anaesthetics. The drugs vary
widely in their chemical structures, and their mechanisms of
CHAPTER 12 General and Local Anaesthetics
TABLE 12.3
197
Adjunct Anaesthetic Drugs
Drug
Pharmacological Class
Usual Dosage Range
Indications/Uses
alfentanil hydrochloride (Alfenta®)
fentanyl citrate!(Fentanyl Citrate injection®)
Opioid analgesic
Initial loading dose: 130 mcg–245 mcg/kg
(with a maintenance infusion of 0.5–
1.5 mcg/kg/minute)
Anaesthesia as an adjunct agent there is
low, moderate and high dose regimens
(ranging from 1 mcg-kg to 20 mcg/kg)
0.5 to 1 mcg/kg/min
50–100 mcg/kg IV
0.5–1 mcg/kg IV
doses up to 8 mcg/kg/IV
Anaesthesia induction
diazepam!(Valium®)
midazolam
Benzodiazepine
2–10 mg PO/IV/IM
1–5 mg IV/IM (Note: midazolam is dosed on
a mg/kg basis depending on if patient is
pre-medicated unmedicated prior to surgery)
Amnesia and anxiety reduction
atropine sulphate
glycopyrrolate
scopolamine
Anticholinergic
Drying up of excessive secretions
morphine sulphate
Opioid analgesic
0.02–0.6 mg/kg IM/subcut
4 mcg/kg IM
Children: 0.006 mg/kg IV/ IM/subcut
Adults: 0.3–0.6 mg IV/IM/subcut
5–20 mg IM/subcut
hydroxyzine
hydrochloride
promethazine
hydrochloride
Antihistamine
25–100 mg PO/IM
25–50 mg IV/IM
Sedation, prevention of nausea and
vomiting, anxiety reduction
pentobarbital sodium
Sedative-hypnotic
150–200 mg IM
Amnesia and sedation
Dexmedetomidine hydrochloride
(Precedex)
α2 agonist
0.2–1.1 mcg/kg/hour doses up to 1.4
mcg/kg/hr have been shown to be effective)
For procedural sedation:
Initial load: 0.5–1 mcg/kg
Maintenance: 0.2–0.6 mcg/kg/hr
Note: dose is different for ICU sedation
Sedation
remifentanil
hydrochloride
sufentanil citrate
Pain prevention and pain relief
IM, intramuscular; IV, intravenous; PO, oral; subcut, subcutaneous.
action are not easily explained by a structure–receptor relationship. The concentrations of various anaesthetics required
to produce a given state of anaesthesia also differ greatly. The
Overton–Meyer theory has been used to explain some of the
properties of anaesthetic drugs since the early days of anaesthesiology. In general terms, it proposes that, for all anaesthetics, potency varies directly with lipid solubility. In other
words, across a continuum of drug potency, fat-soluble drugs
are stronger anaesthetics than water-soluble drugs. Nerve cell
membranes have a high lipid content, as does the blood–brain
barrier (see Chapter 2). Lipid-soluble anaesthetic drugs can
therefore easily cross the blood–brain barrier and concentrate
in nerve cell membranes.
The overall effect of general anaesthetics is a progressive
reduction of sensory and motor CNS functions. The degree and
speed of this process varies with the anaesthetics and adjuncts
used, along with their dosages and routes of administration.
General anaesthesia initially produces a loss of the senses of
sight, touch, taste, smell, and hearing, along with loss of consciousness. Cardiac and pulmonary functions are usually the
last to be interrupted because they are controlled by the medulla
of the brainstem. These are the classical “stages” of anaesthesia. Mechanical ventilatory support is absolutely necessary. In
more extensive surgical procedures, especially those involving
the heart, pharmacological cardiac support involving adrenergic drugs (see Chapter 19) and inotropic drugs (see Chapter 25)
may also be required.
The reactions of various body systems to general anaesthetics
are further described in Table 12.4.
Indications
General anaesthetics are used to produce unconsciousness and
relaxation of skeletal and visceral smooth muscles for surgical
procedures, as well as in electroconvulsive therapy for severe
depression (see Chapter 17).
Contraindications
Contraindications to the use of anaesthetic drugs include
known drug allergy. Depending on the drug type, contraindications may also include pregnancy, narrow-angle glaucoma, and
known susceptibility to malignant hyperthermia (see Adverse
Effects) from prior experience with anaesthetics.
198
PART 2 Drugs Affecting the Central Nervous System
Effects of Inhaled and
Intravenous General Anaesthetics
TABLE 12.4
Organ/System
Reaction
Respiratory system
Depressed muscles and patterns of respiration; altered
gas exchange and reduced oxygenation; depressed
airway-protective mechanisms; airway irritation and
possible laryngospasm
Cardiovascular
system
Depressed myocardium; hypotension and tachycardia;
bradycardia in response to vagal stimulation
Central nervous
system
CNS depression; blurred vision; nystagmus; progression
of CNS depression to decreased alertness and sensorium as well as decreased level of consciousness
Cerebrovascular
system
Increased intracranial blood volume and increased
intracranial pressure
Gastrointestinal
system
Reduced liver blood flow and thus reduced liver clearance
Renal system
Decreased glomerular filtration
Skeletal muscles
Skeletal muscle relaxation
Cutaneous circulation Vasodilation
Adverse Effects
Adverse effects of general anaesthetics are dose dependent and
vary with the individual drug. The heart, peripheral circulation,
liver, kidneys, and respiratory tract are the sites primarily affected.
Pulmonary aspiration is a possible complication of general anaesthesia. Patient-related factors such as a full stomach and diabetes may
place a patient at higher potential for aspiration; this is why adequate
fasting is required prior to elective procedures requiring general
anaesthesia). Myocardial depression is a common adverse effect. All
halogenated anaesthetics are capable of causing hepatotoxicity.
With the development of newer drugs, many of the unwanted
adverse effects characteristic of the older drugs (such as hepatotoxicity and myocardial depression) are now in the past. In addition, many bothersome adverse effects such as nausea, vomiting,
and confusion are less common since balanced anaesthesia has
been widely used. This practice prevents many of the unwanted,
dose-dependent adverse effects and toxicity associated with anaesthetic drugs while also achieving a more balanced general anaesthesia. Substance misuse (e.g., alcohol misuse; see Chapter 18) can
predispose a patient to anaesthetic-induced complications (e.g.,
liver toxicity). A positive history of substance misuse may lead to
dosage adjustments in one or more of the drugs used. A patient
who misuses drugs and has a high tolerance for street drugs may
also require higher doses of anaesthesia-related drugs (e.g., benzodiazepines, opioids) to achieve the desired sedative effects.
Malignant hyperthermia is an uncommon, but potentially
fatal, genetically linked adverse metabolic reaction to general
anaesthesia. It is classically associated with the use of volatile
inhalational anaesthetics as well as the depolarizing NMBD succinylcholine (see Neuromuscular Blocking Drugs, later in this chapter). Signs include rapid rise in body temperature, tachycardia,
tachypnea, and muscular rigidity. Patients known to be at greater
potential for malignant hyperthermia include children, adolescents, and individuals with muscular or skeletal abnormalities
such as hernias, strabismus, ptosis, scoliosis, and muscular dystrophy. Malignant hyperthermia is treated with cardiorespiratory
supportive care as needed to stabilize heart and lung function,
along with the skeletal muscle relaxant dantrolene sodium (see
Chapter 13). All facilities that provide general anaesthesia must
maintain a certain amount of dantrolene sodium on hand in case
of malignant hyperthermia.
Toxicity and Management of Overdose
In large doses, anaesthetics are potentially life threatening,
with cardiac and respiratory arrest as the ultimate causes of
death. However, these drugs are almost exclusively administered in a controlled environment by personnel trained in
advanced cardiac life support. These drugs are also quickly
metabolized. In addition, the medullary centre, which governs
the vital functions, is the last area of the brain to be affected
by anaesthetics and the first to regain function. These factors combined make an anaesthetic overdose rare and easily
reversible.
Interactions
Some of the common drugs that interact with general anaesthetics are antihypertensives and beta blockers, which have
additive effects when given with general anaesthetics (increased
hypotensive effects from antihypertensives; increased myocardial depression with beta blockers). Long-term antihypertensives such as beta blockers are usually discontinued prior to the
procedure requiring a general anaesthetic. No significant laboratory test interactions have been reported.
DOSAGES
Selected General Anaesthetic Drugs
Drug
Pharmacological
Class
Usual Dosage
Range
Halothane® Inhalation general
0.5–1.5% concenanaesthetic (halogetration
nated hydrocarbon)
Indications
General anaesthesia
isoflurane Inhalation general
Induction: 1.5–3%,
General anaes(Forane®) anaesthetic (enflurane Maintenance
thesia
isomer)
0.5–2.5% depending
on concomitant gases
nitrous oxide Inorganic inhalation
(“laughing general anaesthetic
gas”)
20–40% with oxygen Analgesia
(e.g., 70% with 30%
Anaesthesia
oxygen)
Dosages
For the recommended dosages of selected general anaesthetic
drugs, see the Dosages table above.
DRUG PROFILES
The dose of any anaesthetic depends on the complexity of the
surgical procedure to be performed and the physical characteristics of the patient. All general anaesthetics have a rapid
onset of action along with rapid elimination upon discontinuation. Anaesthesia is maintained intraoperatively by continuous
administration of the drug.
CHAPTER 12 General and Local Anaesthetics
SPECIAL POPULATIONS: OLDER ADULTS
Anaesthesia
• Older adult patients are affected more adversely by anaesthesia than young
or middle-aged adult patients. With aging comes organ system deterioration. Declining liver function results in decreased metabolism of drugs, and
a decline in kidney functioning leads to decreased drug excretion. Either of
these can lead to drug toxicity, unsafe levels, or overdose. If both organs
are not functioning properly, the risk of drug toxicity or overdose is even
greater. In addition, the older adult population is more sensitive to the
effects of drugs affecting the central nervous system.
• Presence of cardiac and respiratory diseases places the older adult patient
at higher potential for cardiac dysrhythmias, hypotension, respiratory
depression, atelectasis, or pneumonia during the postanaesthesia and
postoperative phases.
• The practice of polypharmacy is yet another concern in older adults in regard
to administration of any type of anaesthetic. Due to the presence of various
age-related diseases, older patients are generally taking more than one medication. The more drugs a patient is taking, the higher the risk of adverse reactions and drug–drug interactions, including interactions with anaesthetics.
isoflurane
Isoflurane (Forane) is a fluorinated ether that is a chemical isomer
of the older fluorinated ether, enflurane. It has a more rapid onset
of action, causes less cardiovascular depression, and has little or
n